# K112745: V-14 Control Wire Guidewire

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Oct 18, 2011 after 27 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: 2 generations back to K941895 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962572: Scimed Choice PT Vision Ptca Guide Wire, Scimed Life Systems, Inc. (1996) Summary page 1.

## Indications for use
The V-14 ControlWire Guidewires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures. The V-14 ControlWire Guidewires are not intended for use in the cerebral vasculature. The devices are provided non-pyrogenic, sterile, and intended for one procedure only.

Source page: https://510kreport.com/device/K112745
Methodology: https://510kreport.com/methodology