Cleared Traditional

FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560

K071167 · Medigroup, Inc. · Gastroenterology & Urology
Aug 2007
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K071167 is an FDA 510(k) clearance for the FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560, a Catheter, Peritoneal, Long-term Indwelling (Class II — Special Controls, product code FJS), submitted by Medigroup, Inc. (Oswego, US). The FDA issued a Cleared decision on August 31, 2007, 127 days after receiving the submission on April 26, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number K071167 FDA.gov
FDA Decision Cleared SESK
Date Received April 26, 2007
Decision Date August 31, 2007
Days to Decision 127 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FJS — Catheter, Peritoneal, Long-term Indwelling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5630

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