# K033443: Speedlyser Infusion Catheter Kit

- Pathway: 510(k) (Special)
- Applicant: AngioDynamics, Inc.
- Decided: Nov 19, 2003 after 21 days
- Product code: QEY (Mechanical Thrombolysis 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
No predicates in its family tree.
41 later devices descend from it; 2 cite it directly.
0 of 42 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
- K041629: Lysus Infusion System (2004), 39 descendants of its own
- K042456: Lysus Infusion System (2004), 38 descendants of its own
- K051319: Lysus Infusion System (2005), 35 descendants of its own
- K052071: Lysus Infusion System (2005), 34 descendants of its own
- K060422: Lysus Infusion System (2006), 27 descendants of its own

## Indications for use
The ANGIODYNAMICS SpeedLyser Infusion Catheter and its related components are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

Source page: https://510kreport.com/device/K033443
Methodology: https://510kreport.com/methodology