# K113428: Angiojet Ultra DVX Thrombectomy Set

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: Dec 2, 2011 after 11 days
- Product code: QEZ (Aspiration Thrombectomy Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K901627 (1990). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091593: Angio Jet Ultra DVX and Xpeedior Thrombectomy Sets, Possis Medical, Inc. (2009) Summary page 5.
- K101406: Angiojet Solent Proxi Thrombectomy Set Model 109676-001, Medrad Interventional/Possis (2010) Summary page 5.

## Indications for use
The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from: upper and lower extremity peripheral arteries > 3.0mm in diameter, upper extremity peripheral veins > 3.0mm in diameter, ileofemoral and lower extremity veins > 3.0mm in diameter, A-V access conduits > 3.0mm in diameter and for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

Source page: https://510kreport.com/device/K113428
Methodology: https://510kreport.com/methodology