# K951509: Pulse*Spray Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Angiodynamics, Div. E-Z-Em, Inc.
- Decided: Jun 16, 1995 after 74 days
- Product code: QEY (Mechanical Thrombolysis 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
No predicates in its family tree.
71 later devices descend from it; 1 cites it directly.
4 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040013: Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit (2004), 70 descendants of its own
- 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

## Recalls of this device
- Jan 28, 2011 · Not classified · Z-3266-2011: The particular lots of UniFuse Catheters were packaged with the wrong occluding ball guidewires.
- Jan 28, 2011 · Not classified · Z-3267-2011: The particular lots of UniFuse Catheters were packaged with the wrong occluding ball guidewires.

Source page: https://510kreport.com/device/K951509
Methodology: https://510kreport.com/methodology