Cleared Traditional

AUTOMATIC TUBING CLAMP SYSTEM (ATC)

K961364 · Rocky Mountain Research, Inc. · Cardiovascular
Oct 1996
Decision
205d
Days
Class 2
Risk

About This 510(k) Submission

K961364 is an FDA 510(k) clearance for the AUTOMATIC TUBING CLAMP SYSTEM (ATC), a Detector, Bubble, Cardiopulmonary Bypass (Class II — Special Controls, product code KRL), submitted by Rocky Mountain Research, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 31, 1996, 205 days after receiving the submission on April 9, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4205.

Submission Details

510(k) Number K961364 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 1996
Decision Date October 31, 1996
Days to Decision 205 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code KRL — Detector, Bubble, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4205

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