Cleared Traditional

Zenysis Short-Term Dialysis Catheter

K163458 · C.R. Bard, Inc. · Gastroenterology & Urology
Apr 2017
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K163458 is an FDA 510(k) clearance for the Zenysis Short-Term Dialysis Catheter, a Catheter, Hemodialysis, Non-implanted (Class II — Special Controls, product code MPB), submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on April 4, 2017, 116 days after receiving the submission on December 9, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number K163458 FDA.gov
FDA Decision Cleared SEKD
Date Received December 09, 2016
Decision Date April 04, 2017
Days to Decision 116 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code MPB — Catheter, Hemodialysis, Non-implanted
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5540

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