# K042040: Triactiv System

- Pathway: 510(k) (Traditional)
- Applicant: Kensey Nash Corp.
- Decided: Mar 23, 2005 after 237 days
- Product code: NFA (Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K013913 (2002). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013913: Percusurge Guardwire Plus Temporary Occlusion and Aspiration System, Medtronic Percusurge, Inc. (2002) Summary page 6.

## Most influential descendants
- K060651: Proxis System, Model EPS101 (2006), 3 descendants of its own
- K063638: Modification to Proxis System, Model Eps 101 (2007), 1 descendant of its own
- K061772: Triactiv FX Embolic Protection System (2006), 1 descendant of its own
- K073700: 6F Proxis System (2008), 0 descendants of its own
- K073563: Modification to Proxis System (2008), 0 descendants of its own

## Recalls of this device
- May 24, 2006 · Not classified · Z-1219-06: Volume control knob not able to go up to larger diameters
- May 24, 2006 · Not classified · Z-1221-06: volume control knob not able to go up to larger diameters
- May 24, 2006 · Not classified · Z-1220-06: volume control knob not able to go up to larger diameters

## Indications for use
The TriActiv® System is indicated for use in conjunction with percutaneous coronary intervention (PCI), using a 7F guide catheter (without side holes), of diseased saphenous vein coronary bypass grafts ranging from 3.0m to 5.0mm in diameter. The TriActiv® System is intended to protect the distal coronary vasculature by trapping and extracting thrombotic and atheromatous debris liberated during PCI. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.

Source page: https://510kreport.com/device/K042040
Methodology: https://510kreport.com/methodology