# K213854: SavvyWire

- Pathway: 510(k) (Traditional)
- Applicant: Opsens, Inc.
- Decided: Sep 14, 2022 after 278 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: 10 generations back to K823434 (1982). 38 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 43 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 5.
- K191907: OptoWire III, Opsens, Inc. (2020) Summary page 5.
- K192454: Wattson Temporary Pacing Guidewire, Vascular Solutions (2020) Summary page 5.
- K202943: OptoMonitor 3, Opsens, Inc. (2020) Summary page 6.

## Most influential descendants
- 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 SavvyWire™ is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters. Additionally, the SavvyWire™ can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart. The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.

Source page: https://510kreport.com/device/K213854
Methodology: https://510kreport.com/methodology