Cleared Traditional

POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER

K133456 · C.R. Bard, Inc. · Gastroenterology & Urology
Sep 2014
Decision
316d
Days
Class 2
Risk

About This 510(k) Submission

K133456 is an FDA 510(k) clearance for the POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER, a Catheter, Hemodialysis, Triple Lumen, Non-implanted (Class II — Special Controls, product code NIE), submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on September 24, 2014, 316 days after receiving the submission on November 12, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number K133456 FDA.gov
FDA Decision Cleared SEKD
Date Received November 12, 2013
Decision Date September 24, 2014
Days to Decision 316 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code NIE — Catheter, Hemodialysis, Triple Lumen, Non-implanted
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5540
Definition Short-term (< 30 Days) Central Venous Access For Hemodialysis And Apheresis, With A Third Lumen For Infusion.

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