FDA.reportPublic FDA data

SPINR

Primary DI
B0905XGW0
Brand
SPINR
Company
ZIEN MEDICAL TECHNOLOGIES, INC.
Model
5X-GW
Catalog number
5X-GW
Device description
Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature
Published
2022-07-21
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
K141054000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141054000DISTAL ACCESS TORQUE DEVICEDistal Access, LLC2014-12-10DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0905XGW1PackageHIBCC5In Commercial Distribution
B0905XGW2PackageHIBCC2In Commercial Distribution
B0905XGW0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Torque manipulation deviceA sterile hand-operated device intended to be attached to the proximal end of an invasive device (e.g., a catheter, a needle, or a guidewire) to provide the operator with the ability to manually manipulate and control the directional torque (rotation) of the device to which it is attached. This device may be made of plastic or metal materials. This is a single-use device.

Regulatory Flags#

DUNS number
017535668
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B090C140900XO Cross 14C14-090C14-0902022-06-20
B090C14090H0XO Cross 14C14-090-HC14-090-H2022-06-21
B090C141350XO Cross 14C14-135C14-1352022-06-20
B090C14135H0XO Cross 14C14-135-HC14-135-H2022-06-20
B090C141750XO Cross 14C14-175C14-1752022-06-20
B090C14175H0XO Cross 14C14-175-HC14-175-H2022-06-21
B090C35090H0XO Cross 35C35-090-HC35-090-H2022-10-24
B090C351350XO Cross 35C35-135C35-1352022-06-20
B090C35135H0XO Cross 35C35-135-HC35-135-H2022-10-24
B090C35175H0XO Cross 35C35-175-HC35-175-H2022-10-24
00853989006002XableCathXC-014-065AXC-014-065A2018-09-24
00853989006019XableCathXC-014-090AXC-014-090A2018-09-24
00853989006026XableCathXC-014-145AXC-014-145A2018-09-24
00853989006033XableCathXC-018-065AXC-018-065A2018-09-24
00853989006040XableCathXC-018-090AXC-018-090A2018-09-24
00853989006057XableCathXC-018-145AXC-018-145A2018-09-24
00853989006064XableCathXC-035-065AXC-035-065A2018-09-24
00853989006071XableCathXC-035-090AXC-035-090A2018-09-24
00853989006088XableCathXC-035-145AXC-035-145A2018-09-24
00853989006095XableCathXC-014-065BXC-014-065B2018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902192230ARROWTELEFLEX INCORPORATEDDQX2026-08-01
04547327167215CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167222CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167239CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167246CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167253CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167260CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
10801902190908ARROWTELEFLEX INCORPORATEDDQX2026-07-30
10801902198461ARROWTELEFLEX INCORPORATEDDQX2026-07-30
10705032057004AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057011AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057028AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057035AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057042AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057059AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057066AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057073AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057080AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10801902193237ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902193244ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902195101ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902193251ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902193268ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902193275ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902222357ARROWTELEFLEX INCORPORATEDDQX2026-07-27
04260461060036EMERYGLIDENano4Imaging GmbHDQX2026-07-23
07290015107426Drivewire 35 GuidewireRAPID MEDICAL LTDDQX2026-07-20
06936733736951ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-07-10