# K990573: Estech Arterial Remote Access Perfusion Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Estech, Inc.
- Decided: Mar 11, 1999 after 16 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- 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.
2 of 10 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 Arterial Perfusion System: named in the summary without a submission number

## Most influential descendants
- K032632: Remote Access Perfusion Cannula Left Axillary 21 French (2003), 4 descendants of its own
- K083111: Impella 5.0 Catheter Family (2009), 3 descendants of its own
- K080700: Duoflo Catheter (2008), 3 descendants of its own
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K112219: Tapas Catheter (2011), 1 descendant of its own

## Indications for use
The ESTECH Arterial Remote Access Perfusion Cannula is intended for use in arterial perfusion of the aorta, via a femoral artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). The device may also be used to occlude the ascending aorta, deliver cardioplegia solution and vent the aortic root.

Source page: https://510kreport.com/device/K990573
Methodology: https://510kreport.com/methodology