Cleared Traditional

MODIFIED SARNS MEMBRANE OXYGENATOR

K863902 · 3M Health Care, Sarns · Cardiovascular
Dec 1986
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K863902 is an FDA 510(k) clearance for the MODIFIED SARNS MEMBRANE OXYGENATOR, a Gas Control Unit, Cardiopulmonary Bypass (Class II — Special Controls, product code DTX), submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on December 11, 1986, 65 days after receiving the submission on October 7, 1986. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4300.

Submission Details

510(k) Number K863902 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1986
Decision Date December 11, 1986
Days to Decision 65 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DTX — Gas Control Unit, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4300

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