# K073563: Modification to Proxis System

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Jan 31, 2008 after 43 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: 5 generations back to K010579 (2001). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060651: Proxis System, Model EPS101, St Jude Medical (2006) Summary page 3.
- K052523: Proxis System, Velocimed, Inc. (2006) Summary page 2.

## 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 and aid in the removal of fresh, soft emboli and thrombi 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. The device is not intended to be used as a thrombectomy system.

Source page: https://510kreport.com/device/K073563
Methodology: https://510kreport.com/methodology