FDA.reportPublic FDA data

510(k) K222848

Device
pRESET Thrombectomy Device
Applicant
Phenox Limited
510(k) number
K222848
Product code
POL
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-20
Date received
2022-09-21
Regulation
882.5600
Classification name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Catriona Lynch
Address
Kamrick Ct. Ballybrit Business Park Galway IE H91XY38 H91XY38

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code POL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242676pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy DevicePhenox Limited2025-02-28
K231539pRESET LITE Thrombectomy DevicePhenox Limited2023-10-21
K223305Trevo NXT ProVue RetrieverStryker Neurovascular2023-03-29
K210502Trevo NXT ProVue RetrieverStryker Neurovascular2021-08-27
K203358Solitaire X Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2021-03-01
K203219Trevo XP ProVue Retriever and Trevo NXT™ ProVue RetrieverStryker Neurovascular2020-12-29
K193576Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2020-11-20
K200117Trevo NXT ProVue RetrieverStryker2020-02-07
K192207Trevo NXT ProVue RetrieverStryker2019-11-22
K190779Trevo XP ProVue RetrieverStryker2019-06-25
K181807Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2019-03-06
K183022Solitaire 4 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2019-01-29
K181186Solitare Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2018-10-25
K181060Solitaire 2 and Solitaire Platinum Revascularization DeviceMedtronic Neurovascular2018-08-24
K173352Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)Concentric Medical, Inc.2018-02-15