# K040013: Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit

- Pathway: 510(k) (Traditional)
- Applicant: Possis Medical, Inc.
- Decided: May 18, 2004 after 134 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: 3 generations back to K901627 (1990). 7 ancestors in all.
70 later devices descend from it; 5 cite it directly.
4 of 78 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.
- K993564: Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002, Possis Medical, Inc. (2000) Summary page 5.
- K905447: E-Z-EM Pulsed Infusion System, E-Z-Em, Inc. (1991) Summary page 5.
- K951509: Pulse*Spray Infusion System, Angiodynamics, Div. E-Z-Em, Inc. (1995) Summary page 5.
- K780551: I.V. Administration Set with Mini-Spike, National Patent Development Corp. (1978) Summary page 5.

## Most influential descendants
- K052256: Angiojet Xpeedior 120 Catheter (2005), 68 descendants of its own
- K061951: Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120 (2006), 66 descendants of its own
- K071514: Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307 (2007), 63 descendants of its own
- K071342: Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552, 105043, 105041, 106553, 105039 (2007), 34 descendants of its own
- K050794: Angiojet DVX Rheolytic Thrombectomy Catheter (2005), 34 descendants of its own

## Indications for use
1. The AngioJet Xpeedior 120 Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from infrainguinal peripheral arteries >3.0 mm in diameter. 2. The AngioJet Power Pulse Spray Ancillary Kit is intended for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system using the Xpeedior 120 Catheter and the AngioJet System.

Source page: https://510kreport.com/device/K040013
Methodology: https://510kreport.com/methodology