# K971719: Therox Infusion Guidewires

- Pathway: 510(k) (Traditional)
- Applicant: Therox, Inc.
- Decided: Nov 3, 1997 after 178 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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 K883880 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883880: Katzen Thrombolysis Guidewire, Medi-Tech, Inc. (1989) Summary page 2.
- (no number) Advanced Cardiovascular Systems 0.014” Hi Torque Floppy Guidewire: named in the summary without a submission number
- (no number) Advanced Cardiovascular Systems Hi Torque Exchange Guidewire: named in the summary without a submission number

## Indications for use
TherOx Infusion Guidewires are intended for use in facilitating the placement of interventional devices in the cardiovascular and neurovascular system. TherOx Infusion Guidewires are designed for small vessel use. TherOx Infusion Guidewires are also intended to be used for the controlled selective infusion of physician-specified fluid agents before, during or after interventional procedures in the cardiovascular or neurovascular system. TherOx Infusion Guidewires are not intended for delivery of contrast agents. Fluid agents utilized with TherOx Infusion Guidewires should be fully prepared and used according to their manufacturer’s instructions for use. TherOx Infusion Guidewires are not intended for neonatal or pediatric use.

Source page: https://510kreport.com/device/K971719
Methodology: https://510kreport.com/methodology