# K252042: Sync AV II Temporary Pacing Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Swift Sync, Inc.
- Decided: Jul 30, 2026 after 395 days
- Product code: LDF (Electrode, Pacemaker, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K042190 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160260: Tempo Temporary Pacing Lead, Biotrace Medical, Inc. (2016) Summary page 5.

## Indications for use
The Sync-AV II temporary pacing catheter is indicated for use in atrio-ventricular synchronic temporary intracardiac pacing for a maximum of three (3) days and is designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

Source page: https://510kreport.com/device/K252042
Methodology: https://510kreport.com/methodology