# K112219: Tapas Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Thermopeutix, Inc.
- Decided: Nov 18, 2011 after 108 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: 5 generations back to K953533 (1995). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 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.
- K093647: Traxcess Docking Wire, MicroVention, Inc. (2010) Summary page 1.

## Most influential descendants
- K141175: Renovocath RC120 (2014), 0 descendants of its own

## Indications for use
The ThermopeutiX TAPASTM Catheter is intended for general intravascular use in the peripheral vasculature in arteries 1.8 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. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer. The TAPASTM Catheter is contraindicated for use in the coronary and intracranial arteries. The TAPASM Catheter is not intended for embolic protection or as an aspiration catheter.

Source page: https://510kreport.com/device/K112219
Methodology: https://510kreport.com/methodology