FDA.reportPublic FDA data

Selebrek PTCA Balloon Dilatation Catheter

Primary DI
06971591769062
Brand
Selebrek PTCA Balloon Dilatation Catheter
Company
Kossel Medtech (Suzhou) Co., Ltd.
Model
KCTO150006
Published
2026-04-19
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
CodeName
LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211349000Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.2022-01-07LOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971591769062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971591769062069715917690626971591769062

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.

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 DIBrandModelCatalogPublished
06954615602972Falspeed PTA Balloon Dilatation CatheterKPTA20300L2026-05-06
06954615603917Falspeed PTA Balloon Dilatation CatheterKPTA25100S2026-05-06
06954615603924Falspeed PTA Balloon Dilatation CatheterKPTA25120S2026-05-06
06954615603931Falspeed PTA Balloon Dilatation CatheterKPTA25150S2026-05-06
06954615603948Falspeed PTA Balloon Dilatation CatheterKPTA25200S2026-05-06
06954615603955Falspeed PTA Balloon Dilatation CatheterKPTA25250S2026-05-06
06954615603962Falspeed PTA Balloon Dilatation CatheterKPTA25300S2026-05-06
06954615603979Falspeed PTA Balloon Dilatation CatheterKPTA30020S2026-05-06
06954615603986Falspeed PTA Balloon Dilatation CatheterKPTA30030S2026-05-06
06954615603993Falspeed PTA Balloon Dilatation CatheterKPTA30040S2026-05-06
06954615604006Falspeed PTA Balloon Dilatation CatheterKPTA30060S2026-05-06
06954615604013Falspeed PTA Balloon Dilatation CatheterKPTA30080S2026-05-06
06954615604020Falspeed PTA Balloon Dilatation CatheterKPTA30100S2026-05-06
06954615604037Falspeed PTA Balloon Dilatation CatheterKPTA30120S2026-05-06
06954615604044Falspeed PTA Balloon Dilatation CatheterKPTA30150S2026-05-06
06954615604051Falspeed PTA Balloon Dilatation CatheterKPTA30200S2026-05-06
06954615604068Falspeed PTA Balloon Dilatation CatheterKPTA30250S2026-05-06
06954615604075Falspeed PTA Balloon Dilatation CatheterKPTA30300S2026-05-06
06954615604082Falspeed PTA Balloon Dilatation CatheterKPTA35020S2026-05-06
06954615604099Falspeed PTA Balloon Dilatation CatheterKPTA35030S2026-05-06

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
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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