# K980977: Piolax Hydrophilic Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Piolax Medical Devices, Inc.
- Decided: Oct 27, 1998 after 225 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 K924202 (1992). 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)
- K924202: Radifocus (R) (Catheter) Guide Wire, Terumo Medical Corp. (1992) Summary page 2.

## Indications for use
The Piolax Hydrophilic Guidewire is indicated for use for introduction and positioning of catheters within the peripheral vasculature in vascular diagnostic and therapeutic applications, particularly for arterial and venous applications in the cardiac, cerebral, and abdominal regions. The Guidewire is contraindicated for use in coronary vessels.

Source page: https://510kreport.com/device/K980977
Methodology: https://510kreport.com/methodology