# K113182: Edwards Lifesciences Intraclude Intra-Aortic Catheter

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Dec 7, 2011 after 40 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: 1 (1 Class I)
- 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.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974175: Heartport Endoaortic Clamp Catheter, Heartport, Inc. (1997) Summary page 1.

## Recalls of this device
- May 14, 2019 · Class I · Z-1705-2019: Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device w

## Indications for use
The IntraClude Intra-Aortic Occlusion Catheter is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude Intra-Aortic Occlusion 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/K113182
Methodology: https://510kreport.com/methodology