# K093847: Duflo Catheter (Heparin Coated)

- Pathway: 510(k) (Special)
- Applicant: Thermopeutix, Inc.
- Decided: Aug 25, 2010 after 252 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: 4 generations back to K974236 (1999). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080700: Duoflo Catheter, Thermopeutix, Inc. (2008) Summary page 1.

## Indications for use
The DuoFlom 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 DuoFIoTM Catheter is contraindlicated for use in the coronary and intracranial arteries. The DuoFlom Catheter is not intended for embolic protection or as an aspiration catheter.

Source page: https://510kreport.com/device/K093847
Methodology: https://510kreport.com/methodology