Cleared Traditional

K202150 - GlidePath 7.5F Long-Term Dialysis Catheter (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202150 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Nov 2020
Decision
107d
Days
Class 2
Risk

K202150 is an FDA 510(k) clearance for the GlidePath 7.5F Long-Term Dialysis Catheter. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on November 18, 2020 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K202150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 03, 2020
Decision Date November 18, 2020
Days to Decision 107 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 130d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSD Catheter, Hemodialysis, Implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - MSD Catheter, Hemodialysis, Implanted

All 123
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K202150.
Hemodialysis Catheter
K241581 · Haolang Medical USA Corporation · May 2025
End Cap
K210461 · Medical Components Inc (Medcomp) · Sep 2021
GlidePath Retro Long-Term Hemodialysis Catheter
K203575 · C.R. Bard, Inc. · Jul 2021
GlidePath 13F Long-Term Hemodialysis Catheter
K211410 · Bard Peripheral Vascular, Inc. · Jun 2021
Pristine Long-Term Hemodialysis Catheter
K203767 · C B Bard, Inc. · Apr 2021
GlidePath 10F Long-Term Dialysis Catheter
K200627 · C.R. Bard, Inc. · Jun 2020