Cleared Traditional

SARNS FILTERED VENOUS RESERVIOR MODIFICATION

K941654 · 3M Health Care, Sarns · Cardiovascular
Jul 1994
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K941654 is an FDA 510(k) clearance for the SARNS FILTERED VENOUS RESERVIOR MODIFICATION, a Defoamer, Cardiopulmonary Bypass (Class II — Special Controls, product code DTP), submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on July 26, 1994, 112 days after receiving the submission on April 5, 1994. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4230.

Submission Details

510(k) Number K941654 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 1994
Decision Date July 26, 1994
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTP — Defoamer, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4230

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