LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI

Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

ST. JUDE MEDICAL, INC.

The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Lifestream Centrifugel Pump Interface #210pi.

Pre-market Notification Details

Device IDK933014
510k NumberK933014
Device Name:LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
Applicant ST. JUDE MEDICAL, INC. 12 ELIZABETH DR. Chelmsford,  MA  01824
ContactJoseph Magliozzi
CorrespondentJoseph Magliozzi
ST. JUDE MEDICAL, INC. 12 ELIZABETH DR. Chelmsford,  MA  01824
Product CodeKFM  
CFR Regulation Number870.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-06-21
Decision Date1994-09-28

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