FDA.reportPublic FDA data

pRESET® Delta Thrombectomy Device (6mm x 30mm)

Primary DI
05391530910460
Brand
pRESET® Delta Thrombectomy Device (6mm x 30mm)
Company
PHENOX LIMITED
Model
PRE2-6-30
Device 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).
Published
2025-03-03
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
K242676000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242676000pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy DevicePhenox Limited2025-02-28POL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530910460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530910460053915309104605391530910460

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

Sterilization Methods#

Method table
Method

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
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
05391530910125pRESET® Thrombectomy Device (5mm x 40mm)PRE-5-402023-01-24
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

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