Cleared Special

PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

K041796 · Cordis Corporation · Gastroenterology & Urology
Aug 2004
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K041796 is an FDA 510(k) clearance for the PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Cordis Corporation (Miami Lakes, US). The FDA issued a Cleared decision on August 3, 2004, 32 days after receiving the submission on July 2, 2004. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.

Submission Details

510(k) Number K041796 FDA.gov
FDA Decision Cleared SESU
Date Received July 02, 2004
Decision Date August 03, 2004
Days to Decision 32 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FGE — Stents, Drains And Dilators For The Biliary Ducts
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5010

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