GlidePath 13F Long-Term Hemodialysis Catheter
by Bard Peripheral Vascular, Inc. 510(k)
Active
510(k) K211410
Overview
The GlidePath 13F Long-Term Hemodialysis Catheter is a catheter, hemodialysis, implanted (per FDA nomenclature) designed for long-term vascular access. It facilitates hemodialysis, hemoperfusion, or apheresis therapy by providing a reliable conduit for blood circulation in patients requiring sustained vascular access.
This catheter is supplied sterile and intended for single-use. It is classified as a Class II medical device under FDA regulations (876.5540) and has received FDA 510K clearance (K211410). The device is available in a 13 French size and is intended for use in both pediatric, adolescent, and adult patients. Storage and handling must comply with sterile medical device protocols to ensure patient safety.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESK | NumberK211410 | Date4 Jun 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MSD
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5540
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESK Substantially Equivalent — Kit
From the manufacturer
Indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. We've taken the GlidePath™ catheter industry leading symmetric tip design and expanded the offering with a smaller French size and shorter lengths to serve patients more adequately.
Overview Indicated for short-term or long-term vascular access in pediatric, adolescent and adult patients for hemodialysis, hemoperfusion or apheresis We've taken the GlidePath™ Catheter's industry leading symmetric tip design and expanded the offering with smaller French sizes and shorter lengths to more adequately serve patients.
Other devices from Bard Peripheral Vascular, Inc.
Questions
What is the GlidePath 13F Long-Term Hemodialysis Catheter used for?
The GlidePath 13F Long-Term Hemodialysis Catheter is designed to provide a dependable vascular access conduit for patients requiring sustained therapy. It is specifically intended for hemodialysis, hemoperfusion, or apheresis procedures, ensuring continuous blood circulation during these treatments. Its 13 French size accommodates a wide range of patient needs, from pediatric to adult.
How is the GlidePath 13F Long-Term Hemodialysis Catheter supplied and what are its sterility and usage guidelines?
The catheter is supplied sterile and is intended for single-use only. This ensures patient safety by preventing contamination and cross-infection. Sterility must be maintained throughout storage and handling, following standard sterile medical device protocols to preserve its integrity before use.
Is the GlidePath 13F Long-Term Hemodialysis Catheter reusable?
No, the GlidePath 13F Long-Term Hemodialysis Catheter is explicitly designed for single-use. Reuse could compromise sterility and patient safety, so adherence to single-use guidelines is critical. Always follow manufacturer instructions for proper disposal after one use.
What sizes and patient populations is the GlidePath 13F Long-Term Hemodialysis Catheter available for?
This catheter is available exclusively in a 13 French size. It is intended for use across pediatric, adolescent, and adult patients requiring long-term vascular access for hemodialysis, hemoperfusion, or apheresis. The 13F size provides flexibility for various patient anatomies within these age groups.
How should the GlidePath 13F Long-Term Hemodialysis Catheter be stored?
The catheter must be stored according to sterile medical device protocols to maintain its sterility and functionality. This includes keeping it in its original, unopened packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures. Always check the packaging for expiration dates and ensure proper sealing before use.