# K110103: Edwards Lifesciences Left Atrial Pressure Monitor Catheter

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Feb 11, 2011 after 29 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K852197 (1985). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852197: Lap-Cath, Research Medical, Inc. (1985) Summary page 1.

## Indications for use
The Left Atrial Pressure Monitoring Catheters are intended to be used solely in conjunction with a standard hemodynamic pressure monitoring system to obtain continuous central vascular pressures via the left atrium during and/or after cardiac surgery.

Source page: https://510kreport.com/device/K110103
Methodology: https://510kreport.com/methodology