SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X

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 Sarns Centrifugal Pump With Xcoating, Model 164275x.

Pre-market Notification Details

Device IDK020998
510k NumberK020998
Device Name:SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
Applicant TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton,  MD  21921
ContactGarry Courtney
CorrespondentGarry Courtney
TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton,  MD  21921
Product CodeKFM  
CFR Regulation Number870.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-28
Decision Date2002-04-04
Summary:summary

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