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FDA 510(k)

pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device

K-Number: K242676 · 2025-02-28

ApplicantPhenox Limited
Decision Date2025-02-28
Product CodePOL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device is a medical device manufactured by Phenox Limited. It received FDA 510(k) clearance on 2025-02-28 under approval number K242676. 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 Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device?

pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2025-02-28. It is manufactured by Phenox Limited. The 510(k) number is K242676.

When was pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device approved by the FDA?

pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device received FDA 510(k) clearance on 2025-02-28, under approval number K242676.

What company makes pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device?

pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device is manufactured by Phenox Limited.

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

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

Related Clinical Trials

NCT06871683 ClotTriever® Thrombectomy System Use-Result Survey in Japan RECRUITING NCT07544654 DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy NOT_YET_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 NCT07394777 An Open Single-armed Investigation to Evaluate the Safety of pHyph Following a Prolonged Treatment Duration in Adult Women With Bacterial Vaginosis COMPLETED

Other Devices by Phenox Limited

K191687pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire K231539pRESET LITE Thrombectomy Device K222848pRESET Thrombectomy Device

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Official Source

View on FDA Database →

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

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