FDA.reportPublic FDA data

pRESET® Thrombectomy Device (5mm x 40mm)

Primary DI
05391530910125
Brand
pRESET® Thrombectomy Device (5mm x 40mm)
Company
PHENOX LIMITED
Model
PRE-5-40
Device 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).
Published
2023-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NRYCatheter, Thrombus Retriever
POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRYCatheter, Thrombus RetrieverCardiovascular2
POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke TreatmentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222848000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222848000pRESET Thrombectomy DevicePhenox Limited2023-01-20POL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530910125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530910125053915309101255391530910125

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy wire-netA device intended to be percutaneously introduced into the vasculature (coronary, peripheral and/or intracranial) through an appropriate intravascular catheter for the removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction; revascularization may also be achieved through thrombus reorientation. Also referred to as a stent retriever or clot retrieval catheter, it consists of an expanding, stent-like wire net connected to a pusher wire primarily intended to grip and remove the emboli/thrombi; it might include a guide-catheter dedicated to introduction of the wire-net. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
985621869
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391530910231Esperance pHLO Aspiration SystemPHLO-AC-71-1252026-02-10
05391530910248Esperance pHLO Aspiration SystemPHLO-AC-71-1352026-02-10
05391530910460pRESET® Delta Thrombectomy Device (6mm x 30mm)PRE2-6-302025-03-03
05391530910477pRESET® Delta Thrombectomy Device (4mm x 20mm)PRE2-4-202025-03-03
05391530910484pRESET® Delta Thrombectomy Device (5mm x 40mm)PRE2-5-402025-03-03
05391530910491pRESET® Delta LITE Thrombectomy Device (3mm x 20mm)PRE2-LT-3-202025-03-03
05391530910507pRESET® Delta LITE Thrombectomy Device (4mm x 20mm)PRE2-LT-4-202025-03-03
05391530910378pNOVUS 21 Microcatheter (150cm)PNOV-21-1502024-12-02
05391530910392pNOVUS 21 Microcatheter (160cm)PNOV-21-1602024-12-02
05391530910095pRESET® LITE Thrombectomy Device (3mm x 20mm)PRE-LT-3-202023-11-13
05391530910101pRESET® LITE Thrombectomy Device (4mm x 20mm)PRE-LT-4-202023-11-13
05391530910002pRESET® Thrombectomy Device (4mm x 20mm)PRE-4-202023-01-24
05391530910019pRESET® Thrombectomy Device (6mm x 30mm)PRE-6-302023-01-24
05391530910132pNOVUS 21 MicrocatheterPNOV-21-1602023-01-09
05391530910040pORTAL® Steerable Hydrophilic GuidewirePORT-14-200-12020-02-06
05391530910057pORTAL® EXT Extension WirePORT-14-115-1-EX2020-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000974077Riptide™Micro Therapeutics, Inc.NRY2026-03-30
00850083646004NeVasc .070 Aspiration Catheter, 115 cmVesalioNRY2026-03-26
00851279008972NeVasc .070 Aspiration Catheter, 140 cmVesalioNRY2026-03-26
00851279008989NeVasc .070 Aspiration Catheter, 132 cmVesalioNRY2026-03-26
00851279008996NeVasc .070 Aspiration Catheter, 125 cmVesalioNRY2026-03-26
00850014025182APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
00850014025199APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
00850014025205APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
00850014025212APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
10886704088097CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088103CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088110CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088141CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704086512CEREGLIDECerenovus, Inc.NRY2025-09-26
00818075011209SocratesSCIENTIA VASCULAR LLCNRY2025-05-27
00818075011216SocratesSCIENTIA VASCULAR LLCNRY2025-05-27
00853799007541Tenzing 7 Delivery CatheterROUTE 92 MEDICALNRY2024-05-16
10886704085355CEREGLIDECerenovus, Inc.NRY2023-07-07
10886704085386CEREGLIDECerenovus, Inc.NRY2023-07-07
00812212030573Zoom 88 Large Distal Platform SupportIMPERATIVE CARE, INC.NRY2023-06-02
00815948025943RED 72PENUMBRA, INC.NRY2023-01-26
05391530910002pRESET® Thrombectomy Device (4mm x 20mm)PHENOX LIMITEDPOL2023-01-24
05391530910002pRESET® Thrombectomy Device (4mm x 20mm)PHENOX LIMITEDNRY2023-01-24
05391530910019pRESET® Thrombectomy Device (6mm x 30mm)PHENOX LIMITEDPOL2023-01-24
00815948025721RED 43PENUMBRA, INC.NRY2023-01-09
00815948025738RED 43PENUMBRA, INC.NRY2023-01-09
00815948025745RED 43PENUMBRA, INC.NRY2023-01-09
00815948025752RED 43PENUMBRA, INC.NRY2023-01-09
00815948025769RED 43PENUMBRA, INC.NRY2023-01-09
00815948025776RED 43PENUMBRA, INC.NRY2023-01-09