Cleared Traditional

PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)

K121383 · Medical Components, Inc. · Gastroenterology & Urology
Sep 2012
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K121383 is an FDA 510(k) clearance for the PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS), a Catheter, Peritoneal, Long-term Indwelling (Class II — Special Controls, product code FJS), submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on September 5, 2012, 120 days after receiving the submission on May 8, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number K121383 FDA.gov
FDA Decision Cleared SESK
Date Received May 08, 2012
Decision Date September 05, 2012
Days to Decision 120 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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