SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)

Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

3M HEALTH CARE, LTD.

The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for Sarns 7850 Centrifugal Pump (modified).

Pre-market Notification Details

Device IDK915363
510k NumberK915363
Device Name:SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
Applicant 3M HEALTH CARE, LTD. 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor,  MI  48106
ContactNancy P Atwood
CorrespondentNancy P Atwood
3M HEALTH CARE, LTD. 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor,  MI  48106
Product CodeKFM  
CFR Regulation Number870.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-27
Decision Date1993-07-28

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