FDA 510(k)

JETi™Hydrodynamic Thrombectomy System

K-Number: K232458 · 2023-12-19

Decision Date2023-12-19

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 2023-12-19 under 510(k) 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. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K232458.

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

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

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.

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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.