Cleared Special

K211410 - GlidePath 13F Long-Term Hemodialysis Catheter

K211410 is an FDA 510(k) clearance for GlidePath 13F Long-Term Hemodialysis Ca..., manufactured by Bard Peripheral Vascular, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Special 510(k) pathway after a 29-day FDA review.

K211410 · Bard Peripheral Vascular, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2021
Decision
29d
Days
Class 2
Risk

K211410 is an FDA 510(k) clearance for the GlidePath 13F Long-Term Hemodialysis Catheter. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on June 4, 2021 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K211410

510(k) Number K211410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 06, 2021
Decision Date June 04, 2021
Days to Decision 29 days
Submission Type Special
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
102d faster than avg
Panel avg: 131d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

MSD Device Classification - Class 2, Special Controls

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 K211410.
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K210461 · Medical Components Inc (Medcomp) · Sep 2021
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K203575 · C.R. Bard, Inc. · Jul 2021
Pristine Long-Term Hemodialysis Catheter
K203767 · C B Bard, Inc. · Apr 2021
GlidePath 7.5F Long-Term Dialysis Catheter
K202150 · C.R. Bard, Inc. · Nov 2020
Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
K202176 · Medical Components, Inc. (dba MedComp) · Sep 2020
K211410 · GlidePath 13F Long-Term Hemodialysis Catheter
Download PDF FDA Summary Bard Peripheral Vascu…