FDA.reportPublic FDA data

pORTAL® EXT Extension Wire

Primary DI
05391530910057
Brand
pORTAL® EXT Extension Wire
Company
PHENOX LIMITED
Model
PORT-14-115-1-EX
Device description
The pORTAL extension wire is intended to interface with pORTAL Neuro Wire. It is provided sterile and is sold separately in its own packaging configuration. The 115cm extension wire provides a facility to extend the overall length of the pORTAL Neuro Wire. This enables the usable length to be extended during use to aid with over-the wire exchange. This facilitates introduction and positioning of catheters and other interventional devices within the target anatomy, while the guidewire retains its working position at the location of intervention. The stiffness of the extension wire is comparable to the proximal, unground section of the pORTAL Neuro Wire.
Published
2020-02-06
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
MOFGuide, Wire, Catheter, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOFGuide, Wire, Catheter, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191687000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191687000pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension WirePhenox Limited2019-10-09DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530910057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530910057053915309100575391530910057

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular guidewire, manualA long, thin, sterile wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It 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
985621869
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391530910231Esperance pHLO Aspiration SystemPHLO-AC-71-1252026-02-10
05391530910248Esperance pHLO Aspiration SystemPHLO-AC-71-1352026-02-10
05391530910460pRESET® Delta Thrombectomy Device (6mm x 30mm)PRE2-6-302025-03-03
05391530910477pRESET® Delta Thrombectomy Device (4mm x 20mm)PRE2-4-202025-03-03
05391530910484pRESET® Delta Thrombectomy Device (5mm x 40mm)PRE2-5-402025-03-03
05391530910491pRESET® Delta LITE Thrombectomy Device (3mm x 20mm)PRE2-LT-3-202025-03-03
05391530910507pRESET® Delta LITE Thrombectomy Device (4mm x 20mm)PRE2-LT-4-202025-03-03
05391530910378pNOVUS 21 Microcatheter (150cm)PNOV-21-1502024-12-02
05391530910392pNOVUS 21 Microcatheter (160cm)PNOV-21-1602024-12-02
05391530910095pRESET® LITE Thrombectomy Device (3mm x 20mm)PRE-LT-3-202023-11-13
05391530910101pRESET® LITE Thrombectomy Device (4mm x 20mm)PRE-LT-4-202023-11-13
05391530910002pRESET® Thrombectomy Device (4mm x 20mm)PRE-4-202023-01-24
05391530910019pRESET® Thrombectomy Device (6mm x 30mm)PRE-6-302023-01-24
05391530910125pRESET® Thrombectomy Device (5mm x 40mm)PRE-5-402023-01-24
05391530910132pNOVUS 21 MicrocatheterPNOV-21-1602023-01-09
05391530910040pORTAL® Steerable Hydrophilic GuidewirePORT-14-200-12020-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971428595857DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595864DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595871DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595888DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595895DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595901DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595918DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
06971428595925DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.MOF2026-07-03
04547327159517CHIKAI Nexus petitASAHI INTECC CO., LTD.MOF2026-03-18
04547327159524CHIKAI Nexus petitASAHI INTECC CO., LTD.MOF2026-03-18
04547327159531CHIKAI Nexus petitASAHI INTECC CO., LTD.MOF2026-03-18
00850076777326Willow 18 GuidewireArbor Endovascular LLCMOF2026-03-16
00850076777333Willow 18 GuidewireArbor Endovascular LLCMOF2026-03-16
00850076777401Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777418Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777425Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777432Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777449Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777456Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777463Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777470Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
00850076777487Cypress 14 GuidewireArbor Endovascular LLCMOF2026-03-11
07649989542021SmartGUIDE deflectable hydrophilic guidewire Artiria Medical SAMOF2026-03-02
00850076777203Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777210Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777227Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777234Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777241Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777258Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05
00850076777265Willow 14 GuidewireArbor Endovascular LLCMOF2025-12-05