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FDA 510(k)

VASCUTRAK PTA DILATION CATHETER

K-Number: K063657 · 2006-12-12

ApplicantYmed, Inc.
Decision Date2006-12-12
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCUTRAK PTA DILATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Ymed, Inc.. It received FDA 510(k) clearance on 2006-12-12 under 510(k) number K063657. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASCUTRAK PTA DILATION CATHETER?

VASCUTRAK PTA DILATION CATHETER is a medical device that received FDA 510(k) clearance on 2006-12-12. The listed applicant is Ymed, Inc.. The 510(k) number is K063657.

When did VASCUTRAK PTA DILATION CATHETER receive FDA 510(k) clearance?

VASCUTRAK PTA DILATION CATHETER received FDA 510(k) clearance on 2006-12-12, under 510(k) number K063657.

Who is the listed applicant for VASCUTRAK PTA DILATION CATHETER?

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

What is the FDA product code for VASCUTRAK PTA DILATION CATHETER?

The FDA product code for VASCUTRAK PTA DILATION CATHETER is PNO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ymed, Inc. 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.

K082343VASCUTRAK 2, MODELS: V14 AND V18

Related Devices (Code: PNO)

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.

K261778JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC

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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