# K961232: 0.014 Floppy & 0.014 Intermediate Guide Wires W/Phosphorylcholine Polymer Coating & 4CM Radiopaque Tip

- Pathway: 510(k) (Traditional)
- Applicant: Biocompatibles, Ltd.
- Decided: Jun 26, 1996 after 89 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.
No later device cites it as a predicate yet.
0 of 1 device 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

## Indications for use
The Floppy and Intermediate guide wires and predicate devices 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/K961232
Methodology: https://510kreport.com/methodology