TANDEMHEART PUMP

Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

CARDIACASSIST INC.

The following data is part of a premarket notification filed by Cardiacassist Inc. with the FDA for Tandemheart Pump.

Pre-market Notification Details

Device IDK110493
510k NumberK110493
Device Name:TANDEMHEART PUMP
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
Applicant CARDIACASSIST INC. 240 ALPHA DRIVE Pittsburgh,  PA  15238
ContactRobert Bollinger
CorrespondentRobert Bollinger
CARDIACASSIST INC. 240 ALPHA DRIVE Pittsburgh,  PA  15238
Product CodeKFM  
CFR Regulation Number870.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-22
Decision Date2011-09-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00814112020043 K110493 000

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