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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 the device name listed in this FDA 510(k) record. The listed applicant is Phenox Limited. It received FDA 510(k) clearance on 2025-02-28 under 510(k) 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. The listed applicant is Phenox Limited. The 510(k) number is K242676.

When did pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device receive FDA 510(k) clearance?

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

Who is the listed applicant for pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device?

The FDA 510(k) record lists Phenox Limited as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07143019The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial AneurysmsRECRUITINGNCT07748572PMCF Registry to Describe the Safety and Performance of p64, p48 MW and p64 MW in FranceRECRUITING

Other records listing Phenox Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251357Esperance pHLO Aspiration SystemK242420pNOVUS 21 MicrocatheterK231539pRESET LITE Thrombectomy DeviceK222848pRESET Thrombectomy DeviceK221279pNOVUS 21 MicrocatheterK191687pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire

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Related Devices (Code: POL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231539pRESET LITE Thrombectomy DevicePhenox LimitedK223305Trevo NXT ProVue RetrieverStryker NeurovascularK222848pRESET Thrombectomy DevicePhenox LimitedK210502Trevo NXT ProVue RetrieverStryker NeurovascularK203358Solitaire X Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 NeurovascularK203219Trevo XP ProVue Retriever and Trevo NXT™ ProVue RetrieverStryker Neurovascular

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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