Cleared Traditional

PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)

K874650 · Quinton, Inc. · Gastroenterology & Urology
Dec 1987
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K874650 is an FDA 510(k) clearance for the PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM), a Catheter, Peritoneal Dialysis, Single Use (Class II — Special Controls, product code FKO), submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on December 9, 1987, 26 days after receiving the submission on November 13, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number K874650 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1987
Decision Date December 09, 1987
Days to Decision 26 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FKO — Catheter, Peritoneal Dialysis, Single Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5630

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