# K213898: ProTrack Pigtail Wire

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Company, Inc.
- Decided: Mar 1, 2023 after 442 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 K920884 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132623: Medtronic Confida Brecker Curve Guidewire, Medtronic (2013) Summary page 4.

## Indications for use
The ProTrack™ Pigtail Wires are intended for use to introduce and position catheters and other interventional devices within the chambers of the heart, including those used within transcatheter aortic valve procedures (TAVR).

Source page: https://510kreport.com/device/K213898
Methodology: https://510kreport.com/methodology