Vela RX PTA Balloon Dilatation Catheter

Catheter, Angioplasty, Peripheral, Transluminal

Curatia Medical

The following data is part of a premarket notification filed by Curatia Medical with the FDA for Vela Rx Pta Balloon Dilatation Catheter.

Pre-market Notification Details

Device IDK171290
510k NumberK171290
Device Name:Vela RX PTA Balloon Dilatation Catheter
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant Curatia Medical 3227 Kifer Road Santa Clara,  CA  95051
ContactJessica Chiu
CorrespondentBill Jacqmein
JCQ Consulting 11218 Zest Court Blaine,  MN  55449
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-02
Decision Date2017-07-19
Summary:summary

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