Cleared Traditional

K896252 - MODIFIED QUINTON SINGLE LUMEN CATHETER
(FDA 510(k) Clearance)

K896252 · Quinton, Inc. · Gastroenterology & Urology

Jan 1990

Decision

91d

Days

Class 2

Risk

K896252 is an FDA 510(k) clearance for the MODIFIED QUINTON SINGLE LUMEN CATHETER, a Catheter, Hemodialysis, Non-implanted (Class II — Special Controls, product code MPB), submitted by Quinton, Inc. (Bothell, US). The FDA issued a Cleared decision on January 29, 1990, 91 days after receiving the submission on October 30, 1989. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number	K896252 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 30, 1989
Decision Date	January 29, 1990
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—