# K052637: Therox Infusion Catheter, Model Inca-1

- Pathway: 510(k) (Traditional)
- Applicant: Therox, Inc.
- Decided: Mar 8, 2006 after 163 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K853997 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853997: Infusion Catheter, Target Therapeutics (1985) Summary page 1.
- K862117: Tracker Infusion Catheter, Target Therapeutics (1986) Summary page 1.

## Indications for use
The infusion catheter is intended to assist in the controlled infusion of diagnostic or therapeutic solutions into the peripheral or coronary vasculature. The target vessel effective diameter is ≥ 2.0 mm. The catheter is placed by a physician using a guide catheter and over a guidewire that extends beyond the final position of the infusion catheter.

Source page: https://510kreport.com/device/K052637
Methodology: https://510kreport.com/methodology