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FDA 510(k)

Scoreflex PTA Scoring Balloon Catheter

K-Number: K182713 · 2019-06-11

ApplicantOrbusneich Medical Trading, Inc.
Decision Date2019-06-11
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Scoreflex PTA Scoring Balloon Catheter is a medical device manufactured by Orbusneich Medical Trading, Inc.. It received FDA 510(k) clearance on 2019-06-11 under approval number K182713. 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 Scoreflex PTA Scoring Balloon Catheter?

Scoreflex PTA Scoring Balloon Catheter is a medical device that received FDA 510(k) clearance on 2019-06-11. It is manufactured by Orbusneich Medical Trading, Inc.. The 510(k) number is K182713.

When was Scoreflex PTA Scoring Balloon Catheter approved by the FDA?

Scoreflex PTA Scoring Balloon Catheter received FDA 510(k) clearance on 2019-06-11, under approval number K182713.

What company makes Scoreflex PTA Scoring Balloon Catheter?

Scoreflex PTA Scoring Balloon Catheter is manufactured by Orbusneich Medical Trading, Inc..

What is the FDA product code for Scoreflex PTA Scoring Balloon Catheter?

The FDA product code for Scoreflex PTA Scoring Balloon Catheter is PNO.

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Other Devices by Orbusneich Medical Trading, Inc.

K182360Teleport Microcatheter K180921Sapphire II PRO Balloon Dilatation Catheter K173680Sapphire II PRO K173894Jade PTA Balloon Dilatation Catheter K192344Sapphire NC Plus Coronary Dilatation Catheter K200269Sapphire II PRO

View all 7 devices →

Related Devices (Code: PNO)

K152789FLEX SCORING CATHETERVenturemed Group K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc. K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC K202187FLEX Vessel Prep SystemVenturemed Group, Inc.

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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