# K073700: 6F Proxis System

- Pathway: 510(k) (Traditional)
- Applicant: St. Jude Medical, Inc.
- Decided: Oct 2, 2008 after 276 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: 5 generations back to K010579 (2001). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063638: Modification to Proxis System, Model Eps 101, St Jude Medical (2007) Summary page 3.
- K052523: Proxis System, Velocimed, Inc. (2006) Summary page 3.

## Indications for use
The 6F Proxis 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 solutions. The 6F Proxis System is also indicated for use as an aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature. The safety and efficacy of this device as an embolic protection system has not been established. The 6F Proxis System is not indicated for use for embolic protection. The device is not intended to be used as a thrombectomy system.

Source page: https://510kreport.com/device/K073700
Methodology: https://510kreport.com/methodology