# K032261: Trellis Reserve Infusion System

- Pathway: 510(k) (Special)
- Applicant: Bacchus Vascular, Inc.
- Decided: Aug 22, 2003 after 30 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: 6 generations back to K904788 (1990). 10 ancestors in all.
6 later devices descend from it; 1 cites it directly.
2 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023514: Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length), Bacchus Vascular, Inc. (2002)

## Most influential descendants
- K050147: Trellis-8 Peripheral Infusion System (2005), 5 descendants of its own
- K071762: Omniwave Endovascular System (2007), 1 descendant of its own
- K071664: Trellis-6 Peripheral Infusion System (2007), 1 descendant of its own
- K130904: Trellis-8 Peripheral Infusion System (2013), 0 descendants of its own
- K083335: Modified Omniwave Endovascular System (2008), 0 descendants of its own

## Indications for use
The TrellisTMReserve 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/K032261
Methodology: https://510kreport.com/methodology