Cleared Traditional

K953904 - SARNS 9000 UNIVERSAL ROLLER PUMP
(FDA 510(k) Clearance)

K953904 · 3M Health Care, Ltd. · Cardiovascular

Apr 1996

Decision

245d

Days

Class 2

Risk

K953904 is an FDA 510(k) clearance for the SARNS 9000 UNIVERSAL ROLLER PUMP. This device is classified as a Pump, Blood, Cardiopulmonary Bypass, Roller Type (Class II — Special Controls, product code DWB).

Submitted by 3M Health Care, Ltd. (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 FDA review panel. Regulated under 21 CFR 870.4370.

Submission Details

510(k) Number	K953904 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