# K023914: Coaxia Flocontrol Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Coaxia, Inc.
- Decided: Feb 21, 2003 after 88 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: 2 generations back to K974236 (1999). 12 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990487: Equinox Occlusion Balloon System, Micro Therapeutics, Inc. (1999) Summary page 1.
- K974175: Heartport Endoaortic Clamp Catheter, Heartport, Inc. (1997) Summary page 1.
- K991320: Medcomp Duo-Flow II Catheter with Lubricious Heparin, Medical Components, Inc. (1999) Summary page 1.
- K012512: Setpoint Endovascular Temperature Management System, Radiant Medical (2002)

## Most influential descendants
- K080700: Duoflo Catheter (2008), 3 descendants of its own
- K112219: Tapas Catheter (2011), 1 descendant of its own
- K090970: Flocontrol , Model 1028 (2009), 1 descendant of its own
- K192786: Gatekeeper Balloon Catheter (2020), 0 descendants of its own
- K141175: Renovocath RC120 (2014), 0 descendants of its own

## Indications for use
The CoAxia FloControl™ Catheter is intended for use in selectively stopping or controlling blood flow in the peripheral vasculature.

Source page: https://510kreport.com/device/K023914
Methodology: https://510kreport.com/methodology