# K230637: Wattson temporary pacing guidewire (2250)

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, LLC
- Decided: May 5, 2023 after 59 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: 7 generations back to K920884 (1992). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192454: Wattson Temporary Pacing Guidewire, Vascular Solutions (2020) Summary page 4.

## Indications for use
The Wattson temporary pacing guidewire is intended to introduce and position catheters and other interventional devices within the chambers of the heart, including those used within transcatheter aortic valve replacement (TAVR) procedures and balloon aortic valvuloplasty (BAV), while transmitting an electrical signal from an external pulse generator to the heart. The temporary pacing guidewire is not intended to remain in place following the clinical procedure.

Source page: https://510kreport.com/device/K230637
Methodology: https://510kreport.com/methodology