FDA.reportPublic FDA data

Inno-Pathwire

Primary DI
06971564430210
Brand
Inno-Pathwire
Company
Suzhou Innomed Medical Device . Co., Ltd.
Model
IW-14-190-STS
Published
2019-09-20
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
DQXWire, Guide, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182553000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182553000Inno-PathwireSuzhou Innomed Medical Device Co., Ltd.2019-03-11DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971564430217PackageGS15In Commercial Distribution
06971564430210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697156443021716971564430217
06971564430210069715644302106971564430210

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Regulatory Flags#

DUNS number
560446555
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971564432382Inno-pathwireIW-14-300-MDS2023-12-28
06971564430111Inno HydrowireSW-35-150-A-3-D2019-03-22
06971564430159Inno HydrowireSW-35-260-A-3-H2019-03-22
06971564430395Inno HydrowireSW-35-180-A-3-H2020-07-15
06971564430203Inno-PathwireIW-14-190-EXS2019-09-20
16971564430200Inno-PathwireIW-14-190-EXS2019-09-20
16971564430217Inno-PathwireIW-14-190-STS2019-09-20
06971564430197Inno-PathwireIW-14-190-MDS2019-08-16
16971564430118Inno HydrowireSW-35-150-A-3-D2019-03-22
16971564430156Inno HydrowireSW-35-260-A-3-H2019-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07640142811350SET Aspirex™ S 10F 110cmStraub Medical AGDQX2022-06-30
07640142811855SET Rotarex™S 6 F x 110 cmStraub Medical AGDQX2022-05-04
07640142811862SET Rotarex™S 6 F x 135 cm Straub Medical AGDQX2022-05-04
07640142811879SET Rotarex™S 8 F x 85 cm Straub Medical AGDQX2022-05-04
07640142811886SET Rotarex™S 8 F x 110 cmStraub Medical AGDQX2022-05-04
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