# K132175: Edwards Lifesciences Intraclude Intra-Aortic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Sep 13, 2013 after 60 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
2 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K131182: Multifix S Knotless Fixation Device, Arthocare Corporation (2013). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K163693: IntraClude Intra-Aortic Occlusion Device (2017), 0 descendants of its own

## 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
- May 5, 2015 · Class II · Z-1758-2015: Potential device damage on the strain relief near the hub area, which may result in blood leakage.

## 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/K132175
Methodology: https://510kreport.com/methodology