# K053251: Techdevice Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Techdevice Corporation
- Decided: Mar 8, 2006 after 107 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 K933334 (1994). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943737: Microvasive Pathfinder Exchange Guidewire Insurg Pathfinder Guidewire, Boston Scientific Corp (1994) Summary page 1.
- K935997: Platinum Plus Guidewire, Boston Scientific Corp (1994) Summary page 1.
- K933334: Magic Torque Guidewire, Boston Scientific Corp (1994) Summary page 1.

## Most influential descendants
- K110241: Endologix Guidewire (2011), 2 descendants of its own
- K152177: SonoStik IV Guide Wire Introducer (2015), 1 descendant of its own
- K243061: SonoStik Guide Wire Introducer (2024), 0 descendants of its own
- K141218: Zigiwire MODE2 Guidewire Wire System, Zigiwire MODE3 Guidewire Wire System (2014), 0 descendants of its own
- K094062: Percu-Pro Guidewire (2010), 0 descendants of its own

## Indications for use
The TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the peripheral vasculature. This guidewire is not intended for use in the coronary arteries or neurovasculature

Source page: https://510kreport.com/device/K053251
Methodology: https://510kreport.com/methodology