# K013635: Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion Length)

- Pathway: 510(k) (Traditional)
- Applicant: Bacchus Vascular, Inc.
- Decided: Feb 11, 2002 after 98 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: 3 generations back to K904788 (1990). 7 ancestors in all.
75 later devices descend from it; 5 cite it directly.
2 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932616: Scimed (R) Dispatch (TM) Coronary Infusion Catheter, Scimed Life Systems, Inc. (1993) Summary page 5.
- K950907: Pulse*Spray Infusion System, Angiodynamics, Div. E-Z-Em, Inc. (1995) Summary page 5.
- K913517: Isolate Infusion Cathetr System, Lake Region Mfg., Inc. (1991) Summary page 5.
- K981417: Squirt Fluid Delivery System, Merit Medical Systems, Inc. (1998) Summary page 5.

## Most influential descendants
- K021958: Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM Catheter Length 10CM Infusion H (2002), 57 descendants of its own
- K023514: Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length) (2002), 56 descendants of its own
- K030637: Ekos Peripheral Infusion System (2003), 50 descendants of its own
- K033214: Ekos Peripheral Infusion System (2003), 46 descendants of its own
- K041629: Lysus Infusion System (2004), 39 descendants of its own

## Indications for use
The Trellis™ 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/K013635
Methodology: https://510kreport.com/methodology