Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013656790

FEI Number

3013656790

Entity Name

PHENOX LIMITED

City/State/Country

Galway, IE

Establishment Address

Kamrick Court, Ballybrit Business Park, Galway H91XY38, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

phenox Limited (Owner Number: 10061667)

Owner / Operator Contact Address

Kamrick Court, Ballybrit Business Park, Galway, IE-G H91XY38, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242676

PMA Number

N/A

All Registered Proprietary Names

pNOVUS 21 Microcatheter Esperance pHLO Aspiration System pRESET LITE Thrombectomy Device pRESET Thrombectomy Device pORTAL Steerable Hydrophilic Guidewire pNOVUS 21 Microcatheter pRESET Delta LITE Thrombectomy Device pRESET Delta Thrombectomy Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2023-01-06
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2023-01-06
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2026-02-05
POL	Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment	Neurology	Class 2	882.5600	2023-11-09
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2023-11-09
POL	Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment	Neurology	Class 2	882.5600	2023-01-23
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2023-01-23
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2019-11-07
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-11-07
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2024-11-29
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2024-11-29
POL	Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment	Neurology	Class 2	882.5600	2025-03-04
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2025-03-04

Official Correspondent

Gary Brogan

US Agent Details

Maria Little Business: phenox INC Email: maria.little@wallabyphenox.com Phone: (844) 6743669

Related Public Records

Same Entity

phenox Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23
K192019	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	2019-11-08
K230411	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter	2023-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2025	Stryker Neurovascular	2	The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

Similar Registrations

Registration Number	Establishment Name	Location
3031768596	PIRAEUS MEDICAL, INC.	Maple Grove, MN, US
3031311812	TORO NEUROVASCULAR, INC.	Irvine, CA, US
3016800412	ICS MEDICAL DEVICES LTD	Galway Galway (City), IE
3012931345	Stryker Neurovascular	Salt Lake City, UT, US
3003775027	ASAHI INTECC CO., LTD.	SETO Aichi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013656790. Last updated year: 2026. Please use registration number 3013656790 when referencing this establishment in official correspondence.