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FDA 510(k)

pRESET Thrombectomy Device

K-Number: K222848 · 2023-01-20

ApplicantPhenox Limited
Decision Date2023-01-20
Product CodePOL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

pRESET 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 2023-01-20 under 510(k) number K222848. 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 Thrombectomy Device?

pRESET Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is Phenox Limited. The 510(k) number is K222848.

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

pRESET Thrombectomy Device received FDA 510(k) clearance on 2023-01-20, under 510(k) number K222848.

Who is the listed applicant for pRESET 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 Thrombectomy Device?

The FDA product code for pRESET 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 SystemK242676pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy DeviceK242420pNOVUS 21 MicrocatheterK231539pRESET LITE Thrombectomy DeviceK221279pNOVUS 21 MicrocatheterK191687pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire

View all 7 devices →

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.

K242676pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy DevicePhenox LimitedK231539pRESET LITE Thrombectomy DevicePhenox LimitedK223305Trevo NXT ProVue RetrieverStryker NeurovascularK210502Trevo 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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