FDA 510(k)

FLEX SCORING CATHETER

K-Number: K152789 · 2016-05-25

Decision Date2016-05-25

Product CodePNO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FLEX SCORING CATHETER is a medical device manufactured by Venturemed Group. It received FDA 510(k) clearance on 2016-05-25 under approval 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. It is manufactured by Venturemed Group. The 510(k) number is K152789.

When was FLEX SCORING CATHETER approved by the FDA?

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

What company makes FLEX SCORING CATHETER?

FLEX SCORING CATHETER is manufactured by Venturemed Group.

What is the FDA product code for FLEX SCORING CATHETER?

The FDA product code for FLEX SCORING CATHETER is PNO.

Related Clinical Trials

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

Related Devices (Code: PNO)

K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc. K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc. K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC K202187FLEX Vessel Prep SystemVenturemed Group, Inc.

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.