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FDA 510(k)

Ultraverse 014 and 018 PTA Balloon Dilatation Catheters

K-Number: K192318 · 2019-10-03

ApplicantBard Peripheral Vascular, Inc.
Decision Date2019-10-03
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Ultraverse 014 and 018 PTA Balloon Dilatation Catheters is a medical device manufactured by Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2019-10-03 under approval number K192318. 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 Ultraverse 014 and 018 PTA Balloon Dilatation Catheters?

Ultraverse 014 and 018 PTA Balloon Dilatation Catheters is a medical device that received FDA 510(k) clearance on 2019-10-03. It is manufactured by Bard Peripheral Vascular, Inc.. The 510(k) number is K192318.

When was Ultraverse 014 and 018 PTA Balloon Dilatation Catheters approved by the FDA?

Ultraverse 014 and 018 PTA Balloon Dilatation Catheters received FDA 510(k) clearance on 2019-10-03, under approval number K192318.

What company makes Ultraverse 014 and 018 PTA Balloon Dilatation Catheters?

Ultraverse 014 and 018 PTA Balloon Dilatation Catheters is manufactured by Bard Peripheral Vascular, Inc..

What is the FDA product code for Ultraverse 014 and 018 PTA Balloon Dilatation Catheters?

The FDA product code for Ultraverse 014 and 018 PTA Balloon Dilatation Catheters is LIT.

Related Clinical Trials

NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT03791970 Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries RECRUITING NCT06816485 INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis RECRUITING NCT07397390 an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified Lesions ENROLLING_BY_INVITATION NCT05805280 IntravasCular Imaging-Guided Versus AngiogRaphy-GUided Drug-Eluting Stent Implantation for Fermoropopliteal Artery Disease COMPLETED NCT05509296 Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease COMPLETED

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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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