Home GUDID 06954615604563 Falspeed PTA Balloon Dilatation Catheter
Primary DI 06954615604563
Brand Falspeed PTA Balloon Dilatation Catheter
Company Kossel Medtech (Suzhou) Co., Ltd.
Model KPTA70080S
Published 2026-05-06
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name LIT Catheter, Angioplasty, Peripheral, Transluminal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 06954615604563 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06954615604563 06954615604563 6954615604563
GMDN Terms# Term, Definition table Term Definition Peripheral angioplasty balloon catheter, basic A 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.
Regulatory Flags# DUNS number 560219894 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 06954615602972 Falspeed PTA Balloon Dilatation Catheter KPTA20300L 2026-05-06 06954615603917 Falspeed PTA Balloon Dilatation Catheter KPTA25100S 2026-05-06 06954615603924 Falspeed PTA Balloon Dilatation Catheter KPTA25120S 2026-05-06 06954615603931 Falspeed PTA Balloon Dilatation Catheter KPTA25150S 2026-05-06 06954615603948 Falspeed PTA Balloon Dilatation Catheter KPTA25200S 2026-05-06 06954615603955 Falspeed PTA Balloon Dilatation Catheter KPTA25250S 2026-05-06 06954615603962 Falspeed PTA Balloon Dilatation Catheter KPTA25300S 2026-05-06 06954615603979 Falspeed PTA Balloon Dilatation Catheter KPTA30020S 2026-05-06 06954615603986 Falspeed PTA Balloon Dilatation Catheter KPTA30030S 2026-05-06 06954615603993 Falspeed PTA Balloon Dilatation Catheter KPTA30040S 2026-05-06 06954615604006 Falspeed PTA Balloon Dilatation Catheter KPTA30060S 2026-05-06 06954615604013 Falspeed PTA Balloon Dilatation Catheter KPTA30080S 2026-05-06 06954615604020 Falspeed PTA Balloon Dilatation Catheter KPTA30100S 2026-05-06 06954615604037 Falspeed PTA Balloon Dilatation Catheter KPTA30120S 2026-05-06 06954615604044 Falspeed PTA Balloon Dilatation Catheter KPTA30150S 2026-05-06 06954615604051 Falspeed PTA Balloon Dilatation Catheter KPTA30200S 2026-05-06 06954615604068 Falspeed PTA Balloon Dilatation Catheter KPTA30250S 2026-05-06 06954615604075 Falspeed PTA Balloon Dilatation Catheter KPTA30300S 2026-05-06 06954615604082 Falspeed PTA Balloon Dilatation Catheter KPTA35020S 2026-05-06 06954615604099 Falspeed PTA Balloon Dilatation Catheter KPTA35030S 2026-05-06
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08033477048772 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048802 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048833 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048864 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048888 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048925 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048956 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048987 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049014 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049045 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049069 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049076 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049106 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049137 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049168 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049199 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049212 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049229 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049250 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049281 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049311 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049373 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049434 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049397 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049090 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048727 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048734 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048765 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048796 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048819 REEF HP MEDTRONIC, INC. LIT 2016-06-19