FDA.reportPublic FDA data

XableCath

Primary DI
00853989006125
Brand
XableCath
Company
Zien Medical Technologies, LLC
Model
XC-014-090B
Catalog number
XC-014-090B
Device description
XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions.
Published
2018-09-24
Public version status
Update
Distribution status
Not 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
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853989006125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853989006125008539890061258539890061250853989006125

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length0
Guidewire Diameter0

Regulatory Flags#

DUNS number
017535668
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
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00850068519385SAM MedicalIO847-1P2026-09-03
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10853624005015PenBlade Safety Scalpel#11P BladePB-M-11P2020-09-21
10853624005022PenBlade Safety Scalpel#15 BladePB-M-152020-09-21
B0902P0130B0Knight Microcatheter2P0-130-B2P0-130-B2024-04-30
B0902P0130S0Knight Microcatheter2P0-130-S2P0-130-S2024-04-30
B0905XGW0SPINR5X-GW5X-GW2022-07-21
B090A110600Control 11F Mechanical Thrombectomy System, 60cmA11-060A11-0602022-06-29
B090A110900Control 11F Mechanical Thrombectomy SystemA11-090A11-0902022-06-29
B090A50550Aspire Max 5 Aspiration Catheter 55cmA5-055A5-0552017-08-17
B090A51350Control 5F Mechanical Thrombectomy System 135cmA5-135A5-1352017-08-17
B090A61350Control 6F Mechanical Thrombectomy System 135cmA6-135A6-1352017-08-17
B090A70900Control 7F Mechanical Thrombectomy SystemA7-090A7-0902022-06-29
B090A90600Control 9F Mechanical Thrombectomy System, 60cmA9-060A9-0602022-06-29
B090A90900Control 9F Mechanical Thrombectomy System, 90cmA9-090A9-0902022-06-29
B090ARXLP60Control RX-LP Mechanical Thrombectomy System, 136cmARX-LP6ARX-LP62017-08-17
B090ASP10010Control RX-LP Mechanical Thrombectomy SystemASP-1001ASP-10012023-04-26
B090ASP10130Control 7F Mechanical Thrombectomy SystemASP-1013ASP-10132023-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
10841156108267TRAPLINERTELEFLEX INCORPORATEDDQY2026-08-18
00199150070114NAMEDTRONIC, INC.DQY2026-04-13
00199150070121NAMEDTRONIC, INC.DQY2026-04-13
00199150070138NAMEDTRONIC, INC.DQY2026-04-13
00199150070145NAMEDTRONIC, INC.DQY2026-04-13
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111878TURNPIKETELEFLEX INCORPORATEDDQY2025-09-09
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00195451000836Shockwave CS Guide CatheterShockwave Medical, Inc.DQY2025-06-02
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
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