# K970938: Hunter 0.014 Inch Super Soft / Hunter O.014 Inch Soft Guide Wires W/Thromboresistant PC Coating

- Pathway: 510(k) (Traditional)
- Applicant: Biocompatibles Cardiovascular, Inc.
- Decided: Nov 17, 1997 after 249 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 K802473 (1980). 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)
- K802473: Benzalkonium-Heparin Coated Guidewires, Medrad, Inc. (1980)

## Indications for use
The Hunter™ Super Soft and Soft guide wires with phosphorylcholine (PC) coating are intended to facilitate the placement of PTA and/or PTCA balloon catheters within the peripheral and coronary vasculature. This guide wire is 0.014-inch size and designed for safe use within appropriately sized balloon catheters. This device is not for use in the cerebral vasculature.

Source page: https://510kreport.com/device/K970938
Methodology: https://510kreport.com/methodology