Cleared Special

GlidePath 13F Long-Term Hemodialysis Catheter

K211410 · Bard Peripheral Vascular, Inc. · Gastroenterology & Urology
Jun 2021
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K211410 is an FDA 510(k) clearance for the GlidePath 13F Long-Term Hemodialysis Catheter, a Catheter, Hemodialysis, Implanted (Class II — Special Controls, product code MSD), submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on June 4, 2021, 29 days after receiving the submission on May 6, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number K211410 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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