FDA 510(k)

JETi Hydrodynamic Thrombectomy System

K-Number: K243549 · 2025-04-04

Decision Date2025-04-04

Product CodeQEZ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

JETi Hydrodynamic Thrombectomy System is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K243549. 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 2025-04-04. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K243549.

When did JETi Hydrodynamic Thrombectomy System receive FDA 510(k) clearance?

JETi Hydrodynamic Thrombectomy System received FDA 510(k) clearance on 2025-04-04, under 510(k) number K243549.

Who is the listed applicant for JETi Hydrodynamic Thrombectomy System?

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

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

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

Other records listing ABBOTT MEDICAL as applicant

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Official Source

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