# K180726: Savion DLVR Guidewire, Savion FLX Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific, Inc.
- Decided: Jun 18, 2018 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: 5 generations back to K913353 (1991). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030617: PT2 Guide Wire and Addwire Extension Wire, Boston Scientific Scimed, Inc. (2003) Summary page 4.
- K143587: ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire, Boston Scientific Corporation (2015) Summary page 4.

## Indications for use
The Savion DLVR and Savion FLX Guidewires are intended to facilitate the placement of balloon dilatation catheters or other interventional therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. They are not intended for use in the cerebral vasculature.

Source page: https://510kreport.com/device/K180726
Methodology: https://510kreport.com/methodology