Cleared Traditional

GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT

K070048 · Marian Medical, Inc. · Gastroenterology & Urology
Mar 2007
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K070048 is an FDA 510(k) clearance for the GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT, a Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (Class II — Special Controls, product code FCM), submitted by Marian Medical, Inc. (Louisville, US). The FDA issued a Cleared decision on March 15, 2007, 71 days after receiving the submission on January 3, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K070048 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2007
Decision Date March 15, 2007
Days to Decision 71 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code FCM — Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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