Cleared Traditional

Zenysis Short-Term Dialysis Catheter

K153190 · C.R. Bard, Inc. · Gastroenterology & Urology
Jan 2016
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K153190 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 January 5, 2016, 63 days after receiving the submission on November 3, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number K153190 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2015
Decision Date January 05, 2016
Days to Decision 63 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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