# K221575: Pre-Formed Blue

- Pathway: 510(k) (Traditional)
- Applicant: Lake Region Medical
- Decided: Oct 7, 2022 after 128 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.
No later device cites it as a predicate yet.
0 of 4 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.

## Indications for use
The Pre-Formed Blue guidewire is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used during transcatheter aortic valve procedures.

Source page: https://510kreport.com/device/K221575
Methodology: https://510kreport.com/methodology