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pRESET® Delta Thrombectomy Device (5mm x 40mm)

FDA UDIFDA 510(k)

Class II (US FDA UDI)

510(k) K222848

by Phenox Limited

Identity

Trade Name
pRESET® Delta Thrombectomy Device (5mm x 40mm) FDA UDI
Generic Name
Thrombectomy wire-net FDA UDI
Device Name
The pRESET Delta 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
PRE2-5-40 FDA UDI
Description
The pRESET Delta 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
05391530910484 FDA UDI
510(k) Number
K242676 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Thrombectomy wire-net

pRESET® Delta Thrombectomy Device (5mm x 40mm) by Phenox Limited — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Similar devices

Also classified as Thrombectomy wire-net.

Cleared under the same submission

K242676 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Phenox Limited

Sources (2)

  • FDA UDI e7af7514-24ec-434e-9b4f-6cb04be0da34 59 fields · synced Jun 19, 2026
  • FDA 510(k) K222848 1 fields · synced May 25, 2026