FDA.reportPublic FDA data

ATW Marker Wire Steerable Guidewires

Primary DI
10705032056670
Brand
ATW Marker Wire Steerable Guidewires
Company
CORDIS CORPORATION
Model
595MY014
Catalog number
595MY014
Device description
SGW ATW .014 J FLOPPY 300CM
Published
2021-01-26
Public version status
Update
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
K994358000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994358000ATW MARKER WIRE STEERABLE GUIDEWIRECordis Corp.2000-01-13DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032056677PackageGS11In Commercial Distribution
10705032056670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503205667720705032056677
1070503205667010705032056670

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
806136177
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032000109RAIN Sheath® Tibial Pedal IntroducerTP506510NTP506510N2023-05-05
10705032078900RAIN Sheath Transradial506516S506516S2018-10-09
10705032078917RAIN Sheath Transradial506510S506510S2018-10-09
10705032079020RAIN Sheath Transradial506516H506516H2018-10-09
10705032079044RAIN Sheath Transradial506410S506410S2018-10-09
10705032082051RAIN Sheath Transradial506716P20G506716P20G2020-12-17
10705032082099RAIN Sheath Transradial506716N506716N2020-12-17
10705032082181RAIN Sheath Transradial506410N506410N2020-12-17
10705032100007RAIN Sheath® Tibial Pedal IntroducerTP506510STP506510S2023-05-05
20705032081211Brite Tip Radianz6872801356872801352022-03-30
20705032081228Brite Tip Radianz6872801106872801102022-03-30
10705032076845RAILWAYRW5ADTBRW5ADTB2018-05-31
10705032076852RAILWAYRW5VBTHRW5VBTH2018-05-31
10705032076913RAILWAYRW7VBTHRW7VBTH2018-05-31
10705032076920RAILWAYRW7VBTBRW7VBTB2018-05-31
10705032019057VISTA BRITE TIP598941P598941P2024-02-23
10705032019170VISTA BRITE TIP598949P598949P2024-02-23
10705032020138VISTA BRITE TIP67004800670048002024-02-23
10705032042956VISTA BRITE TIPSM7497SM74972024-02-23
10705032043069VISTA BRITE TIPSM7540SM75402024-02-23

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