Cleared Traditional

K892450 - MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS
(FDA 510(k) Clearance)

K892450 · Quinton, Inc. · General & Plastic Surgery

Oct 1989

Decision

184d

Days

Class 1

Risk

K892450 is an FDA 510(k) clearance for the MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS. This device is classified as a Tape And Bandage, Adhesive (Class I — General Controls, product code KGX).

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on October 11, 1989, 184 days after receiving the submission on April 10, 1989.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5240.

Submission Details

510(k) Number	K892450 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 1989
Decision Date	October 11, 1989
Days to Decision	184 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—