Phenox L T D

FDA Filings

This page includes the latest FDA filings for Phenox L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3013656790
• FEI Number: 3013656790
• Name: PHENOX LIMITED
• Owner & Operator: phenox Limited
• Contact Address: Kamrick Court Ballybrit Business Park; Galway IE-G Galway H91XY38 IE
• Official Correspondent:
  • Gary Brogan
  • 353-91-740100-203
• US Agent:
  • James Lago
  • phenox Inc
  • 949 3875210
  • james.lago@phenox.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Kamrick Court Ballybrit Business Park; Galway Galway, H91XY38 IE
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 05391530910248 PHENOX LIMITED	Esperance pHLO Aspiration System	2026-02-18
GUDID 05391530910231 PHENOX LIMITED	Esperance pHLO Aspiration System	2026-02-18
GUDID 05391530910507 PHENOX LIMITED	pRESET® Delta LITE Thrombectomy Device (4mm x 20mm)	2025-03-11
GUDID 05391530910491 PHENOX LIMITED	pRESET® Delta LITE Thrombectomy Device (3mm x 20mm)	2025-03-11
GUDID 05391530910484 PHENOX LIMITED	pRESET® Delta Thrombectomy Device (5mm x 40mm)	2025-03-11
GUDID 05391530910477 PHENOX LIMITED	pRESET® Delta Thrombectomy Device (4mm x 20mm)	2025-03-11
GUDID 05391530910460 PHENOX LIMITED	pRESET® Delta Thrombectomy Device (6mm x 30mm)	2025-03-11
GUDID 05391530910392 PHENOX LIMITED	pNOVUS 21 Microcatheter (160cm)	2024-12-10
GUDID 05391530910378 PHENOX LIMITED	pNOVUS 21 Microcatheter (150cm)	2024-12-10
GUDID 05391530910101 PHENOX LIMITED	pRESET® LITE Thrombectomy Device (4mm x 20mm)	2023-11-21
GUDID 05391530910095 PHENOX LIMITED	pRESET® LITE Thrombectomy Device (3mm x 20mm)	2023-11-21
GUDID 05391530910057 PHENOX LIMITED	pORTAL® EXT Extension Wire	2020-02-14
GUDID 05391530910040 PHENOX LIMITED	pORTAL® Steerable Hydrophilic Guidewire	2020-02-14
PMN K191687 | MOF PHENOX LIMITED	PORTAL Steerable Hydrophilic Guidewire	2019-11-07
PMN K191687 | MOF PHENOX LIMITED	PORTAL EXT Extension Wire	2019-11-07
PMN K191687 | DQX PHENOX LIMITED	PORTAL Steerable Hydrophilic Guidewire	2019-11-07
PMN K191687 | DQX PHENOX LIMITED	PORTAL EXT Extension Wire	2019-11-07
PMN K191687 Phenox Limited	PORTAL Steerable Hydrophilic Guidewire And PORTAL EXT Extension Wire	2019-10-09