# K080700: Duoflo Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Thermopeutix, Inc.
- Decided: Sep 26, 2008 after 199 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). 15 ancestors in all.
3 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)
- K003288: Origen Dual Lumen Catheter, Origen Biomedical, Inc. (2001) Summary page 1.
- K023914: Coaxia Flocontrol Catheter, Coaxia, Inc. (2003) Summary page 1.
- K990573: Estech Arterial Remote Access Perfusion Cannula, Estech, Inc. (1999) Summary page 1.

## Most influential descendants
- K112219: Tapas Catheter (2011), 1 descendant of its own
- K141175: Renovocath RC120 (2014), 0 descendants of its own
- K093847: Duflo Catheter (Heparin Coated) (2010), 0 descendants of its own

## Indications for use
The DuoFIoTM Catheter is intended for general intravascular use in the peripheral vasculature in arteries 3.5 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region when connected to an extracorporeal circuit. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer. The Duo-Flo Catheter is contraindicated for use in the coronary and intracranial arteries. The Duo-Flo Catheter is not intended for embolic protection or as an aspiration catheter.

Source page: https://510kreport.com/device/K080700
Methodology: https://510kreport.com/methodology