# K111182: Angiojet Solent Omni Thrombectomy Set

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: May 24, 2011 after 27 days
- Product code: QEZ (Aspiration Thrombectomy Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 1 (0 Class I)
- 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.
28 later devices descend from it; 2 cite it directly.
1 of 49 devices in its family (counting itself) has a Class I recall.

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

## Most influential descendants
- K151313: ZelanteDVT Thrombectomy Set (2015), 26 descendants of its own
- K193462: ClotTriever Thrombectomy System (2020), 21 descendants of its own
- K210190: ClotTriever Thrombectomy System (2021), 20 descendants of its own
- K210689: ClotTriever Thrombectomy System (2021), 19 descendants of its own
- K212632: ClotTriever Thrombectomy System (2021), 15 descendants of its own

## Recalls of this device
- Jul 31, 2015 · Class II · Z-2378-2015: 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.

## Indications for use
The AngioJet Solent Omni 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/K111182
Methodology: https://510kreport.com/methodology