# K061772: Triactiv FX Embolic Protection System

- Pathway: 510(k) (Traditional)
- Applicant: Kensey Nash Corp.
- Decided: Jul 11, 2006 after 18 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: 2 generations back to K013913 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042040: Triactiv System, Kensey Nash Corp. (2005) Summary page 1.

## Most influential descendants
- K062870: Triactiv FX Embolic Protection System, Model PN 60040-02; -03 (2006), 0 descendants of its own

## Recalls of this device
- Mar 28, 2007 · Not classified · Z-0835-2007: Insufficient wire sealing
- Mar 28, 2007 · Not classified · Z-0834-2007: Insufficient wire sealing
- Mar 28, 2007 · Not classified · Z-0833-2007: Insufficient wire sealing

## Indications for use
The TriActiv FX® Embolic Protection 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 3.0mm to 5.Om in diameter. The TriActiv FX® Embolic Protection System is intended to protect the distal coronary vasculafure 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/K061772
Methodology: https://510kreport.com/methodology