# K153397: S-Wire Guidewire System

- Pathway: 510(k) (Traditional)
- Applicant: Concert Medical, LLC
- Decided: Aug 18, 2016 after 268 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: 3 generations back to K930622 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151244: Pre-Formed Guidewire, Lake Region Medical (2015) Summary page 4.
- K130798: Pre-Formed Guidewires, Lake Region Medical, Inc. (2013) Summary page 4.

## Most influential descendants
- K171445: Amplatz Support Wire Guide with Apex Curve (2018), 0 descendants of its own

## Indications for use
The S-Wire Guidewire System is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used in trans-catheter aortic valve implantation (TAVI) procedures.

Source page: https://510kreport.com/device/K153397
Methodology: https://510kreport.com/methodology