# K052347: Titan Steerable (Ptca) Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Lake Region Mfg., Inc.
- Decided: Feb 17, 2006 after 172 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: 4 generations back to K941895 (1994). 19 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041624: Ptca Steerable Hydrophilic Guidewire, Lake Region Mfg., Inc. (2004) Summary page 3.
- K042854: Stereotaxis Endovascular Guide Wire, Stereotaxis, Inc. (2005) Summary page 3.

## Most influential descendants
- K060454: Titan Guidewire (2006), 1 descendant of its own
- K073655: Pegasus Steerable (Ptca) Guidewire (2008), 0 descendants of its own

## Indications for use
For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

Source page: https://510kreport.com/device/K052347
Methodology: https://510kreport.com/methodology