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FDA 510(k)

Esperance pHLO Aspiration System

K-Number: K251357 · 2026-01-15

ApplicantPhenox, Ltd.
Decision Date2026-01-15
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Esperance pHLO Aspiration System is a medical device manufactured by Phenox, Ltd.. It received FDA 510(k) clearance on 2026-01-15 under approval number K251357. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Esperance pHLO Aspiration System?

Esperance pHLO Aspiration System is a medical device that received FDA 510(k) clearance on 2026-01-15. It is manufactured by Phenox, Ltd.. The 510(k) number is K251357.

When was Esperance pHLO Aspiration System approved by the FDA?

Esperance pHLO Aspiration System received FDA 510(k) clearance on 2026-01-15, under approval number K251357.

What company makes Esperance pHLO Aspiration System?

Esperance pHLO Aspiration System is manufactured by Phenox, Ltd..

What is the FDA product code for Esperance pHLO Aspiration System?

The FDA product code for Esperance pHLO Aspiration System is NRY.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07491952 Continuous Dual Aspiration Technique With Zoom System for Stroke RECRUITING NCT06747117 A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT04798261 Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System RECRUITING NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING

Other Devices by Phenox, Ltd.

K221279pNOVUS 21 Microcatheter K242420pNOVUS 21 Microcatheter

Related Devices (Code: NRY)

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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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