INT,K2 Microcatheter

Primary DI
06950900998898
Brand
INT,K2 Microcatheter
Company
Shanghai Kindly Medical Instruments Co., Ltd.
Model
MCM04-0L
Device description
1.6F-2.3F, 180cm, curved tip,fully hydrophilic coating
Published
2023-08-29
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
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201706000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201706000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26950900998892PackageGS15In Commercial Distribution
46950900998896PackageGS125In Commercial Distribution
06950900998898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2695090099889226950900998892
4695090099889646950900998896
06950900998898069509009988986950900998898

GMDN Terms#

Term, Definition table
TermDefinition
Coronary artery infusion catheterA sterile flexible tube, typically with a double-lumen, designed to access the coronary artery vasculature for local infusion of diagnostic or therapeutic solutions (e.g., angiographic contrast medium, heparin solution, saline), and often to function as a passage for a guidewire to assist its placement in the coronary artery. This is a single-use device.

Regulatory Flags#

DUNS number
420827639
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06950900900693INT,SlideCathACJL605F11252023-09-11
06950900900709INT,SlideCathACJL606F11252023-09-11
06950900900716INT,SlideCathACJR304F11002023-09-11
06950900900723INT,SlideCathACJR307F11002023-09-11
06950900900730INT,SlideCathACJR355F11252023-09-11
06950900900747INT,SlideCathACJR356F11252023-09-11
06950900900754INT,SlideCathACJR405F11252023-09-11
06950900900761INT,SlideCathACJR406F11252023-09-11
06950900900778INT,SlideCathACJR455F11002023-09-11
06950900900785INT,SlideCathACJR456F11002023-09-11
06950900900792INT,SlideCathACJR456F11252023-09-11
06950900900808INT,SlideCathACJR457F11002023-09-11
06950900900815INT,SlideCathACJR505F11252023-09-11
06950900900822INT,SlideCathACJR506F11252023-09-11
06950900900839INT,SlideCathACJR605F11252023-09-11
06950900900846INT,SlideCathACJR606F11252023-09-11
06950900900853INT,SlideCathACTIG24F11002023-09-11
06950900900860INT,SlideCathACTIG25F11002023-09-11
06950900900877INT,SlideCathACTIG27F11002023-09-11
06950900900884INT,SlideCathACTIG34F11002023-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
07613327417203AXS Catalyst 7Stryker CorporationDQY2019-05-13
07613327417227AXS Catalyst 7Stryker CorporationDQY2019-05-13
07613327313888DAC 038Stryker CorporationDQY2016-09-21
07613327313901DAC 057Stryker CorporationDQY2016-09-21
07613327313932DAC 070Stryker CorporationDQY2016-09-21
07613327313949DAC 057Stryker CorporationDQY2016-09-21
08033477054322Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477054360Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477054384Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477054391Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477054407Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477054421Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477054438Pacific™ PlusMEDTRONIC, INC.DQY2016-06-26
08033477048772REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048802REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048833REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048864REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048888REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048925REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048956REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477048987REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049014REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049045REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049069REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049076REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049106REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049137REEF HPMEDTRONIC, INC.DQY2016-06-19
08033477049168REEF HPMEDTRONIC, INC.DQY2016-06-19