# K081021: Kinetix Guidewire, Plus Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Aug 8, 2008 after 120 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: 6 generations back to K913353 (1991). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040140: IQ Guide Wire, Boston Scientific Corp (2004) Summary page 1.

## Most influential descendants
- K193194: CrossTorq 14 Guidewire (2019), 0 descendants of its own

## Indications for use
KinetixTM Guidewires are intended to facilitate placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or PTA or other intravascular interventional procedures. The KinetixTM 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/K081021
Methodology: https://510kreport.com/methodology