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FDA 510(k)

Tri-Wedge PTA Scoring Balloon Dilatation Catheter

K-Number: K241478 · 2024-10-22

ApplicantBrosmed Medical Co., Ltd.
Decision Date2024-10-22
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tri-Wedge PTA Scoring Balloon Dilatation Catheter is a medical device manufactured by Brosmed Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-10-22 under approval number K241478. 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 Tri-Wedge PTA Scoring Balloon Dilatation Catheter?

Tri-Wedge PTA Scoring Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2024-10-22. It is manufactured by Brosmed Medical Co., Ltd.. The 510(k) number is K241478.

When was Tri-Wedge PTA Scoring Balloon Dilatation Catheter approved by the FDA?

Tri-Wedge PTA Scoring Balloon Dilatation Catheter received FDA 510(k) clearance on 2024-10-22, under approval number K241478.

What company makes Tri-Wedge PTA Scoring Balloon Dilatation Catheter?

Tri-Wedge PTA Scoring Balloon Dilatation Catheter is manufactured by Brosmed Medical Co., Ltd..

What is the FDA product code for Tri-Wedge PTA Scoring Balloon Dilatation Catheter?

The FDA product code for Tri-Wedge PTA Scoring Balloon Dilatation Catheter is PNO.

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Other Devices by Brosmed Medical Co., Ltd.

K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter K153742Apollo Balloon Dilatation Catheter K160256Polux , Minerva and Atropos PTA Balloon Dilatation Catheter K203390Artimes pro Balloon Dilatation Catheter K212215Tiche PTA Balloon Dilatation Catheter K230705POT PTCA Balloon Dilatation Catheter

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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 K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc. K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC

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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