# K962510: Heartport Endoaortic Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: Sep 11, 1996 after 76 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Heartport Endoaortic Clamp (Catalog Number 01055): named in the summary without a submission number

## Most influential descendants
- K980631: Embol-X Aortic Occlusion and Cardioplegia Cannula (1999), 0 descendants of its own
- K964161: Heartport Endoaortic Clamp (1997), 0 descendants of its own

## 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.

## 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/K962510
Methodology: https://510kreport.com/methodology