Cleared Traditional

SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION

K941653 · 3M Health Care, Sarns · Cardiovascular
Aug 1994
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K941653 is an FDA 510(k) clearance for the SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION, a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on August 24, 1994, 141 days after receiving the submission on April 5, 1994. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K941653 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 1994
Decision Date August 24, 1994
Days to Decision 141 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTZ — Oxygenator, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4350

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