# K974175: Heartport Endoaortic Clamp Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: Dec 16, 1997 after 40 days
- Product code: DWZ (Device, Biopsy, Endomyocardial)
- Device class: 2
- Regulation: 21 CFR 870.4075
- 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.
9 later devices descend from it; 3 cite it directly.
1 of 10 devices in its family (counting itself) has 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™ catheter: named in the summary without a submission number
- (no number) Medi-tech Occlusion Balloon catheter: named in the summary without a submission number

## Most influential descendants
- K023914: Coaxia Flocontrol Catheter (2003), 6 descendants of its own
- K080700: Duoflo Catheter (2008), 3 descendants of its own
- K112219: Tapas Catheter (2011), 1 descendant of its own
- K090970: Flocontrol , Model 1028 (2009), 1 descendant of its own
- K192786: Gatekeeper Balloon Catheter (2020), 0 descendants of its own

## Recalls of this device
- Sep 24, 2009 · Not classified · Z-0085-2010: Spontaneous balloon rupture during use of the product.
- Apr 12, 2005 · Not classified · Z-0811-05: Guidewire is protruding through the film portion of the packages which compromises the sterility of the device.

## Indications for use
The Heartport Endoaortic Clamp catheter is indicated for use in patients undergoing cardiopulmonary bypass. The Endoaortic Clamp 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/K974175
Methodology: https://510kreport.com/methodology