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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 the device name listed in this FDA 510(k) record. The listed applicant is Curatia Medical. It received FDA 510(k) clearance on 2017-07-19 under 510(k) 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. The listed applicant is Curatia Medical. The 510(k) number is K171290.

When did Vela RX PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Vela RX PTA Balloon Dilatation Catheter?

The FDA 510(k) record lists Curatia Medical as the applicant. This does not by itself establish the device manufacturer.

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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Other records listing Curatia Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220604EXTesia Introducer Sheath SetK180797Xcess Guiding Catheter

Related Devices (Code: LIT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, Inc.K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.

Official Source

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

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