FDA.reportPublic FDA data

Artime Balloon Dilatation Catheter

Primary DI
06958481428186
Brand
Artime Balloon Dilatation Catheter
Company
BrosMed Medical Co.,Ltd.
Model
rev01
Catalog number
801-2008U
Published
2024-12-24
Public version status
New
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
LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOXCatheters, Transluminal Coronary Angioplasty, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06958481428186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06958481428186069584814281866958481428186

GMDN Terms#

Term, Definition table
TermDefinition
Coronary angioplasty balloon catheter, basicA flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. 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
00810219610071FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610088FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610095FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610101FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610118FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
06971591769062Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769079Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769086Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769093Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769109Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769116Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769123Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769130Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769147Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
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