Cleared Traditional

SARNS 800 ROLLER PUMP

K953901 · 3M Health Care, Sarns · Cardiovascular
Apr 1996
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K953901 is an FDA 510(k) clearance for the SARNS 800 ROLLER PUMP, a Pump, Blood, Cardiopulmonary Bypass, Roller Type (Class II — Special Controls, product code DWB), submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on April 19, 1996, 245 days after receiving the submission on August 18, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4370.

Submission Details

510(k) Number K953901 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1995
Decision Date April 19, 1996
Days to Decision 245 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWB — Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4370

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