FDA 510(k)

pRESET LITE Thrombectomy Device

K-Number: K231539 · 2023-10-21

Decision Date2023-10-21

Product CodePOL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

pRESET LITE Thrombectomy Device is a medical device manufactured by Phenox Limited. It received FDA 510(k) clearance on 2023-10-21 under approval number K231539. The device is classified under product code POL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the pRESET LITE Thrombectomy Device?

pRESET LITE Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2023-10-21. It is manufactured by Phenox Limited. The 510(k) number is K231539.

When was pRESET LITE Thrombectomy Device approved by the FDA?

pRESET LITE Thrombectomy Device received FDA 510(k) clearance on 2023-10-21, under approval number K231539.

What company makes pRESET LITE Thrombectomy Device?

pRESET LITE Thrombectomy Device is manufactured by Phenox Limited.

What is the FDA product code for pRESET LITE Thrombectomy Device?

The FDA product code for pRESET LITE Thrombectomy Device is POL.

Related Clinical Trials

NCT06871683 ClotTriever® Thrombectomy System Use-Result Survey in Japan RECRUITING NCT07356284 Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis RECRUITING NCT07566598 Measuring Absolute Brain Flow and Brain Microcirculation Resistance by Continuous Thermodilution RECRUITING NCT07102160 Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking RECRUITING NCT03359434 Blood Pressure Measurement Methods and Prediction of Intracranial Hemorrhage After Thrombectomy in Stroke COMPLETED NCT06733246 Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients RECRUITING

Other Devices by Phenox Limited

K191687pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire K222848pRESET Thrombectomy Device K242676pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device

Related Devices (Code: POL)

K162539Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular DEN150049Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mmConcentric Medical, Inc. K181186Solitare Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K181060Solitaire 2 and Solitaire Platinum Revascularization DeviceMedtronic Neurovascular K173352Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)Concentric Medical, Inc. K192207Trevo NXT ProVue RetrieverStryker

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.