CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)

Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

TERUMO CARDIOVASCULAR SYSTEMS CORP.

The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Capiox Sp Pump (with Or Without X-coating).

Pre-market Notification Details

Device IDK080774
510k NumberK080774
Device Name:CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
Applicant TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton,  MD  21921
ContactGarry A Courtney
CorrespondentGarry A Courtney
TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton,  MD  21921
Product CodeKFM  
CFR Regulation Number870.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2008-03-19
Decision Date2008-04-17
Summary:summary

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