# K033085: Portaclamp

- Pathway: 510(k) (Traditional)
- Applicant: Cardio Life Research, S.A.
- Decided: Apr 27, 2004 after 211 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: 2 generations back to K951413 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974769: Cosgrove Clamp, Allegiance Healthcare Corp. (1998) Summary page 1.
- K962366: Heartport Cable Bulldog Clamp, Heartport, Inc. (1996) Summary page 1.
- K955132: Heartport Endoaortic Clamp, Heartport, Inc. (1996) Summary page 1.

## Most influential descendants
- K070380: Portaclamp Flex (2007), 0 descendants of its own

## Indications for use
The Portaclamp TM 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/K033085
Methodology: https://510kreport.com/methodology