# K041517: Infusioncath

- Pathway: 510(k) (Traditional)
- Applicant: Id, LLC
- Decided: Aug 5, 2004 after 59 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: 4 generations back to K904788 (1990). 9 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013635: Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion Length), Bacchus Vascular, Inc. (2002) Summary page 5.
- K992940: Lemaitre Balloon Catheter with Irrigation, Vascutech, Inc. (2000) Summary page 5.
- K913517: Isolate Infusion Cathetr System, Lake Region Mfg., Inc. (1991) Summary page 5.

## Most influential descendants
- K052738: Infusioncath Peripheral Infusion Catheter, Models VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044 (2005), 1 descendant of its own
- K073400: Varicath Peripheral Infusion Catheter (2007), 0 descendants of its own
- K052844: Kavs - Catheter, Models 1107100 & 1107060 (2006), 0 descendants of its own

## Indications for use
The InfusionCath is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.

Source page: https://510kreport.com/device/K041517
Methodology: https://510kreport.com/methodology