FDA.reportPublic FDA data

Inno-Pathwire

Primary DI
16971564430200
Brand
Inno-Pathwire
Company
Suzhou Innomed Medical Device . Co., Ltd.
Model
IW-14-190-EXS
Published
2019-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
16971564430200PackageGS15In Commercial Distribution
06971564430203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697156443020016971564430200
06971564430203069715644302036971564430203

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
560446555
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
06971564430210Inno-PathwireIW-14-190-STS2019-09-20
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
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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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