pRESET® Thrombectomy Device (5mm x 40mm)

FDA UDI

Class II (US FDA UDI)

by Phenox Limited

Identity

Trade Name: pRESET® Thrombectomy Device (5mm x 40mm) FDA UDI
Generic Name: Thrombectomy wire-net FDA UDI
Device Name: The pRESET Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The device is designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and middle cerebral artery (MCA). FDA UDI
Model / Reference: PRE-5-40 FDA UDI
Description: The pRESET Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The device is designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and middle cerebral artery (MCA). FDA UDI

Identifiers

Primary DI / UDI-DI: 05391530910125 FDA UDI
510(k) Number: K222848 FDA UDI
FDA Product Code: NRY FDA UDI
POL FDA UDI
GMDN Term: Thrombectomy wire-net FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
882.5600 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Thrombectomy wire-net

pRESET® Thrombectomy Device (5mm x 40mm) by Phenox Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thrombectomy wire-net.

Solitaire™ X-PACK — Micro Therapeutics, Inc. · Class II
Solitaire™ X — Micro Therapeutics, Inc. · Class II
ClotTriever XL Catheter — Inari Medical, Inc. · Class II
Solitaire™ X-PACK — Micro Therapeutics, Inc. · Class II
Solitaire™ X — Micro Therapeutics, Inc. · Class II
Solitaire™ X — Micro Therapeutics, Inc. · Class II
Solitaire™ X-PACK — Micro Therapeutics, Inc. · Class II
RevCore Thrombectomy Catheter — Inari Medical, Inc. · Class II

Cleared under the same submission

K222848 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Phenox Limited

Sources (1)

FDA UDI 8d548b03-c343-4367-b201-88bbb6ad279d 35 fields · synced May 30, 2026