# K090970: Flocontrol , Model 1028

- Pathway: 510(k) (Traditional)
- Applicant: Coaxia, Inc.
- Decided: Jun 12, 2009 after 67 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- 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 K974236 (1999). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023914: Coaxia Flocontrol Catheter, Coaxia, Inc. (2003) Summary page 1.

## Most influential descendants
- K192786: Gatekeeper Balloon Catheter (2020), 0 descendants of its own

## Indications for use
The CoAxia FloControl™ Catheter is intended for use in selectively stopping or controlling flow in the peripheral vasculature, which includes the descending aorta.

Source page: https://510kreport.com/device/K090970
Methodology: https://510kreport.com/methodology