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FDA 510(k)

FLEX SCORING CATHETER

K-Number: K152789 · 2016-05-25

ApplicantVenturemed Group
Decision Date2016-05-25
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLEX SCORING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Venturemed Group. It received FDA 510(k) clearance on 2016-05-25 under 510(k) number K152789. 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 FLEX SCORING CATHETER?

FLEX SCORING CATHETER is a medical device that received FDA 510(k) clearance on 2016-05-25. The listed applicant is Venturemed Group. The 510(k) number is K152789.

When did FLEX SCORING CATHETER receive FDA 510(k) clearance?

FLEX SCORING CATHETER received FDA 510(k) clearance on 2016-05-25, under 510(k) number K152789.

Who is the listed applicant for FLEX SCORING CATHETER?

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

What is the FDA product code for FLEX SCORING CATHETER?

The FDA product code for FLEX SCORING CATHETER is PNO.

Other records listing Venturemed Group 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.

K202187FLEX Vessel Prep System

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.

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, LLCK232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)Goodman Co., 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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