# K163693: IntraClude Intra-Aortic Occlusion Device

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jan 26, 2017 after 29 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K132175 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
2 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132175: Edwards Lifesciences Intraclude Intra-Aortic Catheter, Edwards Lifesciences, LLC (2013) Summary page 4.

## 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
- Jan 16, 2019 · Class II · Z-1100-2019: Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device.
- Mar 30, 2018 · Class II · Z-1929-2018: Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.

## Indications for use
The IntraClude™ Intra-Aortic Occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude Intra-Aortic Occlusion device 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/K163693
Methodology: https://510kreport.com/methodology