# K240864: PacePro Wire

- Pathway: 510(k) (Traditional)
- Applicant: Opsens, Inc.
- Decided: May 24, 2024 after 57 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: 11 generations back to K823434 (1982). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213854: SavvyWire, Opsens, Inc. (2022) Summary page 5.

## Indications for use
The PacePro Wire is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures. Additionally, the PacePro Wire can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.

Source page: https://510kreport.com/device/K240864
Methodology: https://510kreport.com/methodology