Serranator PTA Serration Balloon Catheter

Catheter, Percutaneous, Cutting/scoring

Cagent Vascular, LLC

The following data is part of a premarket notification filed by Cagent Vascular, Llc with the FDA for Serranator Pta Serration Balloon Catheter.

Pre-market Notification Details

Device IDK213728
510k NumberK213728
Device Name:Serranator PTA Serration Balloon Catheter
ClassificationCatheter, Percutaneous, Cutting/scoring
Applicant Cagent Vascular, LLC 150 Strafford Avenue #315 Wayne,  PA  19087
ContactCarol Burns
CorrespondentCarol Burns
Cagent Vascular, LLC 150 Strafford Avenue #315 Wayne,  PA  19087
Product CodePNO  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-26
Decision Date2021-12-15

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