# K063638: Modification to Proxis System, Model Eps 101

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: May 11, 2007 after 155 days
- Product code: DQY (Catheter, Percutaneous)
- 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: 4 generations back to K913517 (1991). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 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 2.
- K060651: Proxis System, Model EPS101, St Jude Medical (2006) Summary page 2.

## Most influential descendants
- K073700: 6F Proxis System (2008), 0 descendants of its own

## Indications for use
The Proxis Flow Control system controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporary vessel occlusion to hold a column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solution(s). The safety and efficacy of this device as an embolic protection system has not been established. The Proxis Flow Control System is not indicated for use for embolic protection.

Source page: https://510kreport.com/device/K063638
Methodology: https://510kreport.com/methodology