Cleared Traditional

3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM

K950739 · 3M Health Care, Sarns · Cardiovascular
Nov 1995
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K950739 is an FDA 510(k) clearance for the 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM, a Control, Pump Speed, Cardiopulmonary Bypass (Class II — Special Controls, product code DWA), submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on November 17, 1995, 273 days after receiving the submission on February 17, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4380.

Submission Details

510(k) Number K950739 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 1995
Decision Date November 17, 1995
Days to Decision 273 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWA — Control, Pump Speed, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4380

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