# K072769: Angiojet Ultra; Xmi (105041), XVG (105042) and Spiroflex (106553) Thrombectomy Sets

- Pathway: 510(k) (Traditional)
- Applicant: Possis Medical, Inc.
- Decided: Nov 14, 2007 after 47 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: 4 generations back to K901627 (1990). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960970: Possis Angiojet Rapid Thrombectomy  Catheter System, F105 Catheter,Model 3030C,LF140 Catheter,Model 3040C,Pump Set 3020P, Possis Medical, Inc. (1996) Summary page 7.
- K972610: Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140 Catheter Model 3040C, Possis Medical, Inc. (2000) Summary page 7.
- K042874: Angiojet Xmi Catheter - Rapid Exchange (Xmi-RX), Possis Medical, Inc. (2004) Summary page 7.

## Most influential descendants
- K113363: Angiojet Solent Dista Thrombectomy Set (2012), 0 descendants of its own

## Recalls of this device
- Jul 31, 2015 · Class II · Z-2377-2015: 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 Ultra XMI Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 2 mm in diameter. The AngioJet Ultra XVG Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 3 mm in diameter. The AngioJet Ultra Spiroflex Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 2 mm in diameter.

Source page: https://510kreport.com/device/K072769
Methodology: https://510kreport.com/methodology