Cleared Traditional

MODIFIED USE OF PULL-APART INTRODUCER SET

K871730 · Quinton, Inc. · Gastroenterology & Urology
May 1987
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K871730 is an FDA 510(k) clearance for the MODIFIED USE OF PULL-APART INTRODUCER SET, 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 May 18, 1987, 13 days after receiving the submission on May 5, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number K871730 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 1987
Decision Date May 18, 1987
Days to Decision 13 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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