# K962266: 0.014 Inch Extra Long Floppy and 0.014 Extra Long Intermediate Guide Wires with Phosphorylcholine (PC) Polymer Coating

- Pathway: 510(k) (Traditional)
- Applicant: Biocompatibles Cardiovascular, Inc.
- Decided: Sep 10, 1996 after 90 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 K955135 (1996). 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)
- K955135: 0.014 Intermediate Guide Wire W/Phosphorylcholine Polymer Coating, Biocompatibles, Ltd. (1996) Summary page 1.

## Indications for use
The Floppy and Intermediate Extra Long Guide Wires are intended for use to facilitate the placement of PTA and/or PTCA balloon dilatation catheters within the peripheral or coronary vasculature. The guide wires are designed for safe use with appropriately sized balloon catheters. The guide wires are not intended for use in the cerebral vasculature.

Source page: https://510kreport.com/device/K962266
Methodology: https://510kreport.com/methodology