# K060651: Proxis System, Model EPS101

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Sep 13, 2006 after 184 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K913517 (1991). 13 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042117: Proxis System, Model Eps 101, Velocimed, Inc. (2005) Summary page 1.
- K023691: Boston Scientific Filterwire EX Embolic, Boston Scientific Epi (2003) Summary page 1.
- K023878: Guardwire Temporary Occlusion and Aspiration System, Medtronic Vascular (2003) Summary page 2.
- K042040: Triactiv System, Kensey Nash Corp. (2005) Summary page 2.
- K013913: Percusurge Guardwire Plus Temporary Occlusion and Aspiration System, Medtronic Percusurge, Inc. (2002) Summary page 3.

## Most influential descendants
- K063638: Modification to Proxis System, Model Eps 101 (2007), 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

## Indications for use
The Proxis System is indicated for use as a proximal embolic protection system to prevent distal release of and to aspirate embolic material (thrombus/debris) in saphenous vein coronary bypass graft(s) (3.0 mm -5.0 mm) during percutaneous transluminal coronary angioplasty and/or stenting procedures. The Proxis System is also indicated to control the flow of fluids in the coronary and peripheral vasculature. 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/K060651
Methodology: https://510kreport.com/methodology