FDA.reportPublic FDA data

Tri-Wedge PTA Scoring Balloon Dilatation Catheter

Primary DI
06958481467536
Brand
Tri-Wedge PTA Scoring Balloon Dilatation Catheter
Company
BrosMed Medical Co.,Ltd.
Model
rev 01
Catalog number
21-35E34
Published
2024-11-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PNOCatheter, Percutaneous, Cutting/Scoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNOCatheter, Percutaneous, Cutting/ScoringCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241478000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241478000Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.2024-10-22PNO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06958481467536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06958481467536069584814675366958481467536

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421318800
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941466829177Balloon Inflation Devicerev 01BM-BID-II302026-05-13
06942265520807Parafleet SC 035 PTA Balloon Dilatation Catheterrev 02F35-060200-2002025-05-13
06942265502018Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-035300-0902025-05-09
06942265502025Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040015-0902025-05-09
06942265502032Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040020-0902025-05-09
06942265502049Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040025-0902025-05-09
06942265502056Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040030-0902025-05-09
06942265502063Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040040-0902025-05-09
06942265502070Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040060-0902025-05-09
06942265502087Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040080-0902025-05-09
06942265502094Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040100-0902025-05-09
06942265502100Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040120-0902025-05-09
06942265502117Parafleet SC 014PTA Balloon Dilatation Catheterrev 02F14-040150-0902025-05-09
06942265502124Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040200-0902025-05-09
06942265502131Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040220-0902025-05-09
06942265502148Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-040250-0902025-05-09
06942265502155F14-040300-090rev 01F14-040300-0902025-05-09
06942265502162Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-045015-0902025-05-09
06942265502179Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-045020-0902025-05-09
06942265502186Parafleet SC 014 PTA Balloon Dilatation Catheterrev 02F14-045025-0902025-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923533801330Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801347Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801354Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801361Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801378Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801385Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801392Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801408Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801415Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801422Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801439Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801446Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801453Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801460Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801477Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801484Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801491Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801507Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801514Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801521Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801538Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801545Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801552Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801569Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801576Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801583Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801590Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801606Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801613Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801620Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30