Capiox ICP Centrifugal Pump

Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

Terumo Cardiovascular Systems Corporation

The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for Capiox Icp Centrifugal Pump.

Pre-market Notification Details

Device IDK200091
510k NumberK200091
Device Name:Capiox ICP Centrifugal Pump
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
Applicant Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor,  MI  48103
ContactJohn Chesney
CorrespondentJohn Chesney
Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor,  MI  48103
Product CodeKFM  
CFR Regulation Number870.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-16
Decision Date2021-11-18

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