# K112694: Edwards Lifesciences Endoclamp Aortic Catheter

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Oct 14, 2011 after 29 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- 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 K974175 (1997). 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)
- K974175: Heartport Endoaortic Clamp Catheter, Heartport, Inc. (1997) Summary page 1.

## Indications for use
The EndoClamp Aortic Catheter is indicated for use in patients undergoing cardiopulmonary bypass. The EndoClamp Aortic Catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.

Source page: https://510kreport.com/device/K112694
Methodology: https://510kreport.com/methodology