FDA.reportPublic FDA data

Selethru NC PTCA Balloon Dilatation Catheter

Primary DI
06971591765675
Brand
Selethru NC PTCA Balloon Dilatation Catheter
Company
Kossel Medtech (Suzhou) Co., Ltd.
Model
KNC225010
Published
2021-09-20
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
LOCSystem, Rf/Microwave Hyperthermia, Cancer Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOCSystem, Rf/Microwave Hyperthermia, Cancer TreatmentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211393000Selethru(TM) NC PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.2021-07-02LOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971591765675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971591765675069715917656756971591765675

GMDN Terms#

Term, Definition table
TermDefinition
Coronary angioplasty balloon catheter, perfusingA sterile, flexible tube designed for use in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon. The tube contains holes proximal and distal to the balloon that permit blood flow to the distal coronary arteries during balloon dilatation to protect the myocardium from haemodynamic compromise. This is a single-use device.

Sterilization Methods#

Method table
Method

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
00864445000434BSD-500 Hyperthermia SystemPyrexar Medical Inc.LOC2023-07-18
08644450004342BSD-500 Hyperthermia SystemPyrexar Medical Inc.LOC2023-05-24
00851551005194BSD-500 Hyperthermia SystemBSD MEDICAL CORPORATIONLOC2014-09-24