# K130798: Pre-Formed Guidewires

- Pathway: 510(k) (Traditional)
- Applicant: Lake Region Medical, Inc.
- Decided: Aug 23, 2013 after 154 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: 1 generation back to K930622 (1993). 1 ancestor in all.
11 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930622: Amplatz Guidewires, Meadox Medicals, Div. Boston Scientific Corp. (1993) Summary page 1.

## Most influential descendants
- K151244: Pre-Formed Guidewire (2015), 10 descendants of its own
- K213854: SavvyWire (2022), 4 descendants of its own
- K241418: OptoMonitor 3 (2025), 1 descendant of its own
- K153397: S-Wire Guidewire System (2016), 1 descendant of its own
- K251367: OptoMonitor 3 (2026), 0 descendants of its own

## Indications for use
The Pre-Formed guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those within transcatheter aortic valve procedures. This guidewire is not intended for use in the cerebrovasculature or coronary arteries.

Source page: https://510kreport.com/device/K130798
Methodology: https://510kreport.com/methodology