Cleared Traditional

CATHETEO CLAMP

K771421 · Quinton, Inc. · Gastroenterology & Urology
Oct 1977
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K771421 is an FDA 510(k) clearance for the CATHETEO CLAMP, a Clamp, Non-electrical (Class I — General Controls, product code FFN), submitted by Quinton, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 25, 1977, 85 days after receiving the submission on August 1, 1977. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4730.

Submission Details

510(k) Number K771421 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 1977
Decision Date October 25, 1977
Days to Decision 85 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FFN — Clamp, Non-electrical
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.4730