# K130904: Trellis-8 Peripheral Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Oct 25, 2013 after 207 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K904788 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050147: Trellis-8 Peripheral Infusion System, Bacchus Vascular, Inc. (2005) Summary page 5.

## Recalls of this device
- Mar 23, 2015 · Class II · Z-1365-2015: Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems due to potential for a sterility breach of the outer packaging or pouch material. 
- Dec 10, 2014 · Class I · Z-1018-2015: A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. Units have been identified to have the distal balloon inflation port inc

## Indications for use
The Trellis-8 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/K130904
Methodology: https://510kreport.com/methodology