# K192454: Wattson Temporary Pacing Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions
- Decided: Jan 15, 2020 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: 6 generations back to K920884 (1992). 11 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181001: Medtronic Confida Brecker Guidewire, Medtronic Core Valve, LLC (2018) Summary page 4.
- K800298: Usci Bipolar Ballon Pacing Electrode, C.R. Bard, Inc. (1980) Summary page 5.

## Most influential descendants
- K213854: SavvyWire (2022), 4 descendants of its own
- K241418: OptoMonitor 3 (2025), 1 descendant of its own
- K251367: OptoMonitor 3 (2026), 0 descendants of its own
- K252674: Solo Pace Fusion System (SOLOFUSE1) (2026), 0 descendants of its own
- K240864: PacePro Wire (2024), 0 descendants of its own

## 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/K192454
Methodology: https://510kreport.com/methodology