# K170258: SpeedLyser Infusion Catheter Kit

- Pathway: 510(k) (Special)
- Applicant: AngioDynamics, Inc.
- Decided: Feb 21, 2017 after 25 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
Longest line of descent: 1 generation back to K033443 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033443: Speedlyser Infusion Catheter Kit, AngioDynamics, Inc. (2003) Summary page 4.

## Indications for use
The SpeedLyser Infusion Catheter Kit is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

Source page: https://510kreport.com/device/K170258
Methodology: https://510kreport.com/methodology