Cleared Traditional

SWAN-NECK PERITONEAL DIALYSIS CATHETERS

K862046 · Accurate Surgical Instruments Co. · Gastroenterology & Urology
Jun 1986
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K862046 is an FDA 510(k) clearance for the SWAN-NECK PERITONEAL DIALYSIS CATHETERS, 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 June 19, 1986, 21 days after receiving the submission on May 29, 1986. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number K862046 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 1986
Decision Date June 19, 1986
Days to Decision 21 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

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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