# K955132: Heartport Endoaortic Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: Jun 7, 1996 after 211 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.
4 later devices descend from it; 3 cite it directly.
0 of 5 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) Medi-tech Occlusion Balloon Catheter: named in the summary without a submission number
- (no number) RMI Coronary Sinus Perfusion & Pressure Monitoring Cannulae: named in the summary without a submission number
- (no number) Cooley Aortic Clamp: named in the summary without a submission number
- (no number) DLP Cardioplegia Pressure Cannula with Vent Line: named in the summary without a submission number
- (no number) Datascope PERCLUDER™ - DL Occluding Balloon: named in the summary without a submission number
- (no number) Fogarty Occluding Catheter: named in the summary without a submission number

## Most influential descendants
- K033085: Portaclamp (2004), 1 descendant of its own
- K070380: Portaclamp Flex (2007), 0 descendants of its own
- K964161: Heartport Endoaortic Clamp (1997), 0 descendants of its own
- K962858: Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog Number Ecpb-a) Antegrade/Retrograde System (1996), 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 cardioplegia, and monitoring of aortic root pressure during cardiopulmonary bypass.

Source page: https://510kreport.com/device/K955132
Methodology: https://510kreport.com/methodology