Cleared Special

DUAL LUMEN CATHETER

K043581 · Acmi Corporation · Gastroenterology & Urology
Mar 2005
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K043581 is an FDA 510(k) clearance for the DUAL LUMEN CATHETER, a Catheter, Ureteral, Gastro-urology (Class II — Special Controls, product code EYB), submitted by Acmi Corporation (Southborough, US). The FDA issued a Cleared decision on March 3, 2005, 65 days after receiving the submission on December 28, 2004. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K043581 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2004
Decision Date March 03, 2005
Days to Decision 65 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code EYB — Catheter, Ureteral, Gastro-urology
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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