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FDA 510(k)

Vela RX PTA Balloon Dilatation Catheter

K-Number: K171290 · 2017-07-19

ApplicantCuratia Medical
Decision Date2017-07-19
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vela RX PTA Balloon Dilatation Catheter is a medical device manufactured by Curatia Medical. It received FDA 510(k) clearance on 2017-07-19 under approval number K171290. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vela RX PTA Balloon Dilatation Catheter?

Vela RX PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2017-07-19. It is manufactured by Curatia Medical. The 510(k) number is K171290.

When was Vela RX PTA Balloon Dilatation Catheter approved by the FDA?

Vela RX PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2017-07-19, under approval number K171290.

What company makes Vela RX PTA Balloon Dilatation Catheter?

Vela RX PTA Balloon Dilatation Catheter is manufactured by Curatia Medical.

What is the FDA product code for Vela RX PTA Balloon Dilatation Catheter?

The FDA product code for Vela RX PTA Balloon Dilatation Catheter is LIT.

Related Clinical Trials

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Related Devices (Code: LIT)

K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K162316Pirouette 014Arravasc, Ltd. K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018Boston Scientific Corporation K161427Pirouette 035Arravasc Limited K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160004Crosstella OTWKANEKA Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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