FloPump 57mL Centrifugal Pump

Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

International Biophysics Corporation

The following data is part of a premarket notification filed by International Biophysics Corporation with the FDA for Flopump 57ml Centrifugal Pump.

Pre-market Notification Details

Device IDK193663
510k NumberK193663
Device Name:FloPump 57mL Centrifugal Pump
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
Applicant International Biophysics Corporation 2101 E. St. Elmo Road Austin,  TX  78744
ContactGeoff Marcek
CorrespondentGeoff Marcek
International Biophysics Corporation 2101 E. St. Elmo Road Austin,  TX  78744
Product CodeKFM  
CFR Regulation Number870.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-31
Decision Date2021-03-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00814321020445 K193663 000
00814321020438 K193663 000

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