SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF

Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

ARIES MEDICAL, INC.

The following data is part of a premarket notification filed by Aries Medical, Inc. with the FDA for Sjm/cad Isoflow(tm) Centrifugal Pump 2100cp, Modif.

Pre-market Notification Details

Device IDK912604
510k NumberK912604
Device Name:SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
Applicant ARIES MEDICAL, INC. 12 ELIZABETH DR. Chelmsford,  MA  01824
ContactJoseph Curtis
CorrespondentJoseph Curtis
ARIES MEDICAL, INC. 12 ELIZABETH DR. Chelmsford,  MA  01824
Product CodeKFM  
CFR Regulation Number870.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-31
Decision Date1991-10-28

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