Cleared Traditional

SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER

K950042 · Accurate Surgical Instruments Co. · Gastroenterology & Urology
Dec 1995
Decision
344d
Days
Class 2
Risk

About This 510(k) Submission

K950042 is an FDA 510(k) clearance for the SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER, a Catheter, Peritoneal, Long-term Indwelling (Class II — Special Controls, product code FJS), submitted by Accurate Surgical Instruments Co. (Toronto Canado M5v 1y9, CA). The FDA issued a Cleared decision on December 15, 1995, 344 days after receiving the submission on January 5, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number K950042 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 1995
Decision Date December 15, 1995
Days to Decision 344 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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