# K200674: AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector

- Pathway: 510(k) (Abbreviated)
- Applicant: Atrility Medical, LLC
- Decided: Jul 2, 2020 after 108 days
- Product code: DSA (Cable, Transducer And Electrode, Patient, (Including Connector))
- Device class: 2
- Regulation: 21 CFR 870.2900
- 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 K022075 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080621: Fastlock, Model PC175M01, PC175MCE, PC005R01, European Custom Manufacturing BV (2008) Summary page 4.
- K070926: Electrode/Extension Cables, Models Atar, Oscor, Inc. (2007) Summary page 4.

## Indications for use
The AtriAmp supports pacing by acting as an extension cable between an external pacemaker and cardiac pacing leads. The AtriAmp also supports monitoring of intra-cardiac signals by transmitting signals to one of the unipolar precordial chest leads (leads V1-V6) of a Type CF, defibrillation-proof ECG monitor.

Source page: https://510kreport.com/device/K200674
Methodology: https://510kreport.com/methodology