# K070380: Portaclamp Flex

- Pathway: 510(k) (Traditional)
- Applicant: Cardio Life Research, S.A.
- Decided: Jun 8, 2007 after 120 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
Longest line of descent: 3 generations back to K951413 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033085: Portaclamp, Cardio Life Research, S.A. (2004) Summary page 3.
- K974769: Cosgrove Clamp, Allegiance Healthcare Corp. (1998) Summary page 3.

## Indications for use
The Portaclamp®Flex is indicated to clamp the aorta during minimally invasive cardiac surgery implying the usage of an extra-corporeal circulation.

Source page: https://510kreport.com/device/K070380
Methodology: https://510kreport.com/methodology