# K082199: Spiralfuse Peripheral Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Bacchus Vascular, Inc.
- Decided: Oct 17, 2008 after 74 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: 9 generations back to K904788 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071664: Trellis-6 Peripheral Infusion System, Bacchus Vascular, Inc. (2007) Summary page 5.

## Indications for use
SpiralFuse Peripheral Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Source page: https://510kreport.com/device/K082199
Methodology: https://510kreport.com/methodology