AngioJet Solent Dista Thrombectomy Set

• • Terminated Z-2379-2015 FDA Class II ·initiated 31 Jul 2015 ·on shared 510(k) K113363

  AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K113363 ↗

FDA Product Code

QEZ

Device Class

Class II

Regulation

21 CFR Part 870.5150

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the AngioJet Solent Dista Thrombectomy Set used for?

  The AngioJet Solent Dista Thrombectomy Set is a catheter-based system designed for the removal of thrombus from blood vessels. It utilizes high-velocity saline jets to create a vacuum effect that breaks up and removes clots from upper and lower extremity peripheral arteries greater than 1.5mm in diameter.

• How is the AngioJet Solent Dista Thrombectomy Set supplied?

  The AngioJet Solent Dista Thrombectomy Set is supplied as a complete set and is intended for single use in cardiovascular procedures. It is designed to be used with the AngioJet Ultra Console and the AngioJet Ultra Power Pulse Kit for selective infusion of physician-specified fluids.

• Is the AngioJet Solent Dista Thrombectomy Set reusable or single-use?

  The AngioJet Solent Dista Thrombectomy Set is intended for single use only. It is supplied as a set and should not be reused or resterilized for patient safety and device performance reasons.

• What is the regulatory status of the AngioJet Solent Dista Thrombectomy Set?

  The AngioJet Solent Dista Thrombectomy Set is a Class II device cleared by the FDA under 510(k) K113363. It has been determined to be substantially equivalent to existing devices for removing thrombus from peripheral blood vessels.