SARNS 9000 WITH CENTRIFUGAL PUMP OPTION

Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

3M HEALTH CARE, SARNS

The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns 9000 With Centrifugal Pump Option.

Pre-market Notification Details

Device IDK884659
510k NumberK884659
Device Name:SARNS 9000 WITH CENTRIFUGAL PUMP OPTION
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
Applicant 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor,  MI  48106
ContactW O'donnell
CorrespondentW O'donnell
3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor,  MI  48106
Product CodeKFM  
CFR Regulation Number870.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-07
Decision Date1989-01-24

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