LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST

Pump, Blood, Cardiopulmonary Bypass, 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 Large (6) Roller Pump For Terumo Advanced Perfusion System 1; Large (6) Roller Pump For Terumo Advanced Perfusion Syst.

Pre-market Notification Details

Device IDK131618
510k NumberK131618
Device Name:LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST
ClassificationPump, Blood, Cardiopulmonary Bypass, Roller Type
Applicant Terumo Cardiovascular Systems Corporation 6200 JACKSON RD. Ann Arbor,  MI  48103
ContactJohn Chesney
CorrespondentJohn Chesney
Terumo Cardiovascular Systems Corporation 6200 JACKSON RD. Ann Arbor,  MI  48103
Product CodeDWB  
CFR Regulation Number870.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-03
Decision Date2013-09-27
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.