Cleared Traditional

MODIFIED PERM-CATH

K900835 · Quinton, Inc. · Gastroenterology & Urology
May 1990
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K900835 is an FDA 510(k) clearance for the MODIFIED PERM-CATH, a Catheter, Subclavian (Class II — Special Controls, product code LFJ), submitted by Quinton, Inc. (Bothell, US). The FDA issued a Cleared decision on May 9, 1990, 76 days after receiving the submission on February 22, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number K900835 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 1990
Decision Date May 09, 1990
Days to Decision 76 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code LFJ — Catheter, Subclavian
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5540

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