# K094062: Percu-Pro Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Cardiosolutions, Inc.
- Decided: Sep 27, 2010 after 270 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: 2 generations back to K770977 (1977). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053251: Techdevice Guidewire, Techdevice Corporation (2006) Summary page 1.
- K963320: TFX Medical Guidewire, Tfx Medical Group (1996) Summary page 1.

## Indications for use
The Percu-ProTm Guidewire is intended to facilitate the placement of devices during diagnostic and interventional vascular procedures in the peripheral vasculature. The guidewire is not intended for use in coronary arteries or for neurovascular use.

Source page: https://510kreport.com/device/K094062
Methodology: https://510kreport.com/methodology