FDA.reportPublic FDA data

510(k) K241478

Device
Tri-Wedge PTA Scoring Balloon Dilatation Catheter
Applicant
Brosmed Medical Co., Ltd.
510(k) number
K241478
Product code
PNO
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-22
Date received
2024-05-24
Regulation
870.1250
Classification name
Catheter, Percutaneous, Cutting/Scoring
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Crystal Lee
Address
15th Bldg., Smes Venture Park Songshan Lake Hi-Tech Industrial Development Zone Dongguan CN 523808 523808

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PNO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.2026-02-04
K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.2025-04-22
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K232207D·Kutting™ PTA Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.2024-03-07
K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC2022-10-18
K220704Serranator PTA Serration Balloon CatheterCagent Vascular, LLC2022-05-04
K213728Serranator PTA Serration Balloon CatheterCagent Vascular, LLC2021-12-15
K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC2020-12-22
K202187FLEX Vessel Prep SystemVenturemed Group, Inc.2020-09-11
K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific2020-05-29
K193181Serranator PTA Serration Balloon CatheterCagent Vascular, LLC2020-04-15
K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc.2019-06-11
K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard2017-09-22