Cleared Traditional

GlidePath 10F Long-Term Dialysis Catheter

K200627 · C.R. Bard, Inc. · Gastroenterology & Urology
Jun 2020
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K200627 is an FDA 510(k) clearance for the GlidePath 10F 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 June 22, 2020, 104 days after receiving the submission on March 10, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number K200627 FDA.gov
FDA Decision Cleared SESK
Date Received March 10, 2020
Decision Date June 22, 2020
Days to Decision 104 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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