# K964161: Heartport Endoaortic Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: Apr 4, 1997 after 169 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955132 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962510: Heartport Endoaortic Clamp, Heartport, Inc. (1996) Summary page 1.
- K955132: Heartport Endoaortic Clamp, Heartport, Inc. (1996) Summary page 1.

## Recalls of this device
- Sep 24, 2009 · Not classified · Z-0084-2010: Balloon catheters were spontaneously rupturing during use.
- Sep 24, 2009 · Not classified · Z-0085-2010: Spontaneous balloon rupture during use of the product.
- Nov 26, 2008 · Not classified · Z-0644-2009: Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173.
- Nov 26, 2008 · Not classified · Z-0645-2009: Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173.

## Indications for use
Occlusion of the aorta, delivery of cardioplegic solution, and monitoring of aortic root pressure during cardiopulmonary bypass.

Source page: https://510kreport.com/device/K964161
Methodology: https://510kreport.com/methodology