# K090253: Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040-001

- Pathway: 510(k) (Traditional)
- Applicant: Possis Medical, Inc.
- Decided: Apr 8, 2009 after 65 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: 8 generations back to K901627 (1990). 17 ancestors in all.
32 later devices descend from it; 1 cites it directly.
1 of 50 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082382: Angiojet Ultra Avx Thrombectomy Set, Model 105039, Possis Medical, Inc. (2008) Summary page 6.
- K072269: Angiojet Ultra DVX Thrombectomy Set, Model: 106552, Possis Medical, Inc. (2007) Summary page 6.
- K071342: Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552, 105043, 105041, 106553, 105039, Possis Medical, Inc. (2007) Summary page 6.
- K071336: Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307, Possis Medical, Inc. (2007) Summary page 6.
- K071514: Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307, Possis Medical, Inc. (2007)
- K993564: Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002, Possis Medical, Inc. (2000) Summary page 6.
- K960970: Possis Angiojet Rapid Thrombectomy  Catheter System, F105 Catheter,Model 3030C,LF140 Catheter,Model 3040C,Pump Set 3020P, Possis Medical, Inc. (1996) Summary page 6.

## Most influential descendants
- K091593: Angio Jet Ultra DVX and Xpeedior Thrombectomy Sets (2009), 31 descendants of its own
- K101406: Angiojet Solent Proxi Thrombectomy Set Model 109676-001 (2010), 30 descendants of its own
- K111182: Angiojet Solent Omni Thrombectomy Set (2011), 28 descendants of its own
- K151313: ZelanteDVT Thrombectomy Set (2015), 26 descendants of its own
- K193462: ClotTriever Thrombectomy System (2020), 21 descendants of its own

## Indications for use
The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from * Upper and Lower extremity peripheral arteries > 3 mm in diameter * Upper extremity peripheral veins > 3 mm in diameter Ileofemoral and lower extremity veins > 3 mm in diameter * AV access conduits > 3 mm 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. The AngioJet Ultra Xpeedior Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from * Upper and Lower extremity peripheral arteries > 3 mm in diameter * Upper extremity peripheral veins > 3 mm in diameter * Ileofemoral and lower extremity veins > 3 mm in diameter * AV access conduits > 3 mm 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/K090253
Methodology: https://510kreport.com/methodology