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FDA 510(k)

JETi™Hydrodynamic Thrombectomy System

K-Number: K232458 · 2023-12-19

ApplicantABBOTT MEDICAL
Decision Date2023-12-19
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

JETi™Hydrodynamic Thrombectomy System is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2023-12-19 under approval number K232458. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JETi™Hydrodynamic Thrombectomy System?

JETi™Hydrodynamic Thrombectomy System is a medical device that received FDA 510(k) clearance on 2023-12-19. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K232458.

When was JETi™Hydrodynamic Thrombectomy System approved by the FDA?

JETi™Hydrodynamic Thrombectomy System received FDA 510(k) clearance on 2023-12-19, under approval number K232458.

What company makes JETi™Hydrodynamic Thrombectomy System?

JETi™Hydrodynamic Thrombectomy System is manufactured by ABBOTT MEDICAL.

What is the FDA product code for JETi™Hydrodynamic Thrombectomy System?

The FDA product code for JETi™Hydrodynamic Thrombectomy System is QEZ.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT06871683 ClotTriever® Thrombectomy System Use-Result Survey in Japan RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING NCT07335341 Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System RECRUITING NCT07135895 The ArtixASCEND Study RECRUITING

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Related Devices (Code: QEZ)

K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC K173266Octane aspiration systemVascular Solutions, Inc. K172000ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC K163051ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC K182232Octane Mechanical Thrombectomy SystemVascular Solutions, Inc. K192439JETi Peripheral Thrombectomy SystemWalk Vascular, LLC

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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