# K042874: Angiojet Xmi Catheter - Rapid Exchange (Xmi-RX)

- Pathway: 510(k) (Special)
- Applicant: Possis Medical, Inc.
- Decided: Nov 5, 2004 after 18 days
- Product code: QEZ (Aspiration Thrombectomy Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K901627 (1990). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972610: Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140 Catheter Model 3040C, Possis Medical, Inc. (2000) Summary page 5.

## Most influential descendants
- K072769: Angiojet Ultra; Xmi (105041), XVG (105042) and Spiroflex (106553) Thrombectomy Sets (2007), 1 descendant of its own
- K113363: Angiojet Solent Dista Thrombectomy Set (2012), 0 descendants of its own
- K080806: Angiojet Ultra Spiroflex VG Thrombectomy Set, Model 106608 (2008), 0 descendants of its own

## Recalls of this device
- May 1, 2007 · Not classified · Z-0955-2007: Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters.
- Dec 12, 2005 · Not classified · Z-0469-06: It was reported that the catheter model inside the product tray and box was not an XMI RX Plus, but an XMI over-the-wire model.

## Indications for use
The AngioJet XMI Catheter — Rapid Exchange is indicated for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries >2mm in diameter.

Source page: https://510kreport.com/device/K042874
Methodology: https://510kreport.com/methodology