AC3 Series Intra-Aortic Balloon Pump (IABP)

System, Balloon, Intra-aortic And Control

Arrow International, Teleflex

The following data is part of a premarket notification filed by Arrow International, Teleflex with the FDA for Ac3 Series Intra-aortic Balloon Pump (iabp).

Pre-market Notification Details

Device IDK192238
501k NumberK192238
Device Name:AC3 Series Intra-Aortic Balloon Pump (IABP)
ClassificationSystem, Balloon, Intra-aortic And Control
Applicant Arrow International, Teleflex 16 Elizabeth Drive Chelmsford,  MA  01824
ContactDeb Fleetham
CorrespondentDeb Fleetham
Arrow International, Teleflex 16 Elizabeth Drive Chelmsford,  MA  01824
Product CodeDSP  
CFR Regulation Number870.3535 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
501k Review PanelCardiovascular
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-19
Decision Date2019-11-12

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