SARN CENTRIFUGAL PUMP

Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

TERUMO CARDIOVASCULAR SYSTEMS

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

Pre-market Notification Details

Device IDK112229
510k NumberK112229
Device Name:SARN CENTRIFUGAL PUMP
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
Applicant TERUMO CARDIOVASCULAR SYSTEMS 6200 JACKSON RD Ann Arbor,  MI  48103
ContactRebecca Andersen
CorrespondentRebecca Andersen
TERUMO CARDIOVASCULAR SYSTEMS 6200 JACKSON RD Ann Arbor,  MI  48103
Product CodeKFM  
CFR Regulation Number870.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-03
Decision Date2011-12-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00699753450417 K112229 000
50699753450344 K112229 000
50699753450337 K112229 000
50699753450320 K112229 000
00699753002333 K112229 000

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