Cleared Traditional

GlidePath 7.5F Long-Term Dialysis Catheter

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

About This 510(k) Submission

K202150 is an FDA 510(k) clearance for the GlidePath 7.5F Long-Term Dialysis Catheter, a Catheter, Hemodialysis, Implanted (Class II — Special Controls, product code MSD), submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on November 18, 2020, 107 days after receiving the submission on August 3, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number K202150 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MSD — Catheter, Hemodialysis, Implanted
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5540

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