# K955135: 0.014 Intermediate Guide Wire W/Phosphorylcholine Polymer Coating

- Pathway: 510(k) (Traditional)
- Applicant: Biocompatibles, Ltd.
- Decided: Apr 9, 1996 after 152 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Advanced Cardiovascular Systems, Inc. 0.014” Hi-Torque Floppy II® Guide Wire: named in the summary without a submission number
- (no number) Advanced Cardiovascular Systems, Inc. 0.014” Hi-Torque Intermediate® Guide Wire: named in the summary without a submission number

## Most influential descendants
- K962266: 0.014 Inch Extra Long Floppy and 0.014 Extra Long Intermediate Guide Wires with Phosphorylcholine (PC) Polymer Coating (1996), 0 descendants of its own

## Indications for use
The Floppy and Intermediate 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 a 0.014 inch size and 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/K955135
Methodology: https://510kreport.com/methodology