AngioJet Ultra Power Pulse Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K130381 ↗

FDA Product Code

QEW

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 Ultra Power Pulse Kit used for?

  The AngioJet Ultra Power Pulse Kit is designed for mechanical thrombectomy, specifically targeting thrombus removal in venous systems, and is used for the control and selective infusion of physician-specified fluids, including thrombolytic agents, into the peripheral vascular system when used with the AngioJet Ultra Thrombectomy Sets.

• How is the AngioJet Ultra Power Pulse Kit supplied?

  The device is supplied as a kit for use with the AngioJet Ultra Thrombectomy Sets, meaning it is not a standalone device but part of a system requiring compatible components for operation in peripheral vascular procedures.

• Is the AngioJet Ultra Power Pulse Kit intended for single-use or reuse?

  While the provided data does not explicitly state single-use or reuse, the device is supplied as a kit for use with thrombectomy sets and is designed for infusion and aspiration in vascular procedures, which typically indicates single-use due to sterility and safety requirements in thrombectomy applications.

• What regulatory pathway was used for the AngioJet Ultra Power Pulse Kit?

  The device received FDA 510(k) clearance under K130381, indicating it was found substantially equivalent to a legally marketed predicate device through the traditional 510(k) pathway, and is classified as a Class II device with product code QEW.