July 1, 2021

C.R. Bard, Inc.

Joan Bergstrom
Regulatory Affairs Specialist
1625 W. Third Street
Tempe, Arizona 85281

Re: K203575
Trade/Device Name: GlidePath™ Retro Long-Term Hemodialysis Catheter
Regulation Number: 21 CFR 876.5540
Regulation Name: Blood access device and accessories
Regulatory Class: Class II
Product Code: MSD
Dated: May 27, 2021
Received: May 28, 2021

Dear Joan Bergstrom:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. However, you are responsible to determine that the medical devices you use as
components in the kit have either been determined as substantially equivalent under the premarket
notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the
enactment date of the Medical Device Amendments. Please note: If you purchase your device components
in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including
these components in your kit/tray. The general controls provisions of the Act include requirements for annual
registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding
and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties.
We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.26
Silver Spring, MD 20993
www.fda.gov
K203575 - Joan Bergstrom Page 2

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,
Gema Gonzalez -S
for Carolyn Y. Neuland, Ph.D.
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity and Transplant Devices
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 K203575
Page 1 of 4

GlidePath™ Retro Long-Term Hemodialysis Catheter

510(k) Summary
21 CFR 807.92

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of
the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence
determination is based is as follows:

Submitter Information:

Applicant: Bard Peripheral Vascular, Inc

1625 West 3rd Street
Tempe, Arizona 85281

Phone: 480-597-8425

Fax: 480-449-2546

Contact: Joan Bergstrom, Regulatory Affairs Specialist

Date May 27, 2021

Subject Device Name:

Device Trade Name: GlidePath™ Retro Long-Term Hemodialysis

Catheter

Common or Usual Name: Catheter, Hemodialysis, Implanted

Device Classification: Class II

Classification Name: Blood Access Device and Accessories

Product Code: MSD

Regulation Number: 21 CFR 876.5540

Review Panel: Gastroenterology/Urology

Predicate Device:

Bard GlidePath™ Long-Term Dialysis Catheter (K190527, cleared March 5, 2020)

Retrograde Placement Reference Device:

Covidien Palindrome™ Precision RT Chronic Catheter Kit (K111817, cleared August 30, 2011)
 K203575
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Device Description:

The GlidePath™ Retro Long-Term Hemodialysis Catheter features a dual-lumen polyurethane

catheter shaft with optimized double-D cross-sectional design providing separate arterial and
venous lumens, an external bifurcation hub with SwiftClick connector assembled by physician
upon placement, and arterial and venous extension legs that connect to an external dialysis
machine or blood cleansing device. The arterial (red) luer connector secures to the blood intake
on the dialysis machine and the venous (blue) luer connector secures to the blood return line on
the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access
to the lumen. The symmetrical catheter tip contains holes that aid in the distribution of blood flow
or aid in over-the-guidewire placement. The dialysis catheter is offered in various lengths.
GlidePath™ Retro Long-Term Hemodialysis Catheters diameter and tip to cuff lengths are listed
below.

GlidePath™ Retro Long-Term

Attribute
Hemodialysis Catheter Product Offerings
Catheter Diameter (F) 14.5
Catheter Shaft Length, Tip to Cuff (cm) 15, 19, 23, 27, 31, 35, 42, 50

Indications for Use of Device:

The GlidePath™ Retro Long-Term Hemodialysis Catheters are indicated for use in attaining
short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy.
Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer
than 40 cm are intended for femoral vein insertion.

Comparison to Predicate and Reference Devices:

The GlidePath™ Retro Long-Term Hemodialysis Catheter has the following similarities to the
predicate, GlidePath™ Long-Term Hemodialysis Catheter (K190527, cleared March 5, 2020):
 Same catheter shaft material
 Same intended use
 Same indications for use
 Same patient target population
 Same operating principle
 Same fundamental scientific technology
 K203575
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 Same packaging configurations

 Same sterility assurance level and method of sterilization

The main difference between the subject device, GlidePath™ Retro Long-Term Hemodialysis
Catheter, and the predicate GlidePath™ Long-Term Hemodialysis Catheter is the retrograde
placement technique and external bifurcation connector for which the reference device, Covidien
Palindrome™ Precision RT Chronic Catheter Kit (K111817, cleared August 30, 2011) and its
bifurcation connector serves as technology comparison.

Performance Data:

To demonstrate substantial equivalence of the subject device to the predicate device, both
technical characteristics and performance criteria were evaluated. Using FDA Guidance
Documents on non-clinical testing of medical devices and internal Risk Assessment procedures,
tests for the following characteristics and performance criteria were performed on the subject
device:
• Extension Leg to Bifurcation Tensile
• Bifurcation to Catheter Shaft while assembled with Swiftclick Tensile
• Flow Rate
• Recirculation
• Mechanical Hemolysis
• Catheter Assembly Leak
• Catheter Burst
• Surface Inspection
• Stylet to Luer Tensile
• Stylet Assembly Leak
• Priming Luer Interface
• Catheter Cap to Tunneler Rod Tensile
• Tunneler Rod Malleability
• Package Performance
• Sterility and Endotoxin
• Biocompatibility per ISO 10993
• Human Factors Evaluation
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The required retrograde placement technology comparison of specific device characteristics

including the external hub connector is made to the reference device, Palindrome™ Precision RT
Chronic Catheter Kit (K111817, cleared August 30, 2011). The results of these comparisons and
tests performed in accordance with standards and FDA guidance, demonstrate that the technical
characteristics and performance criteria of the GlidePath™ Retro Long-Term Hemodialysis
Catheter is substantially equivalent to the predicate, comparable in technology to the reference,
and that it can perform in a manner equivalent to devices currently on the market for the same
intended use.

Conclusion:

The subject device, the GlidePath™ Retro Long-Term Hemodialysis Catheter, met all
predetermined acceptance criteria of design verification and validation as specified by applicable
standards, guidance, test protocols and/or customer inputs. The subject, predicate, and reference
devices share the same or similar characteristics: catheter shaft material, intended use,
indications for use, target patient population, operating principle, fundamental scientific
technology, packaging configurations, and sterility assurance level and method of sterilization.
Therefore, Bard Peripheral Vascular, Inc. concludes that the subject device GlidePath™ Retro
Long-Term Hemodialysis Catheter is substantially equivalent to the legally marketed predicate
device, GlidePath™ Long-Term Hemodialysis Catheter and comparable to the legally marketed
reference device Palindrome™ Precision RT Chronic Catheter Kit.