# K141175: Renovocath RC120

- Pathway: 510(k) (Traditional)
- Applicant: Renovorx, Inc.
- Decided: Oct 24, 2014 after 171 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K953533 (1995). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112219: Tapas Catheter, Thermopeutix, Inc. (2011) Summary page 4.

## Recalls of this device
- Nov 25, 2015 · Class II · Z-0565-2016: Incorrect version of Instructions for Use were shipped to two US customers.

## Indications for use
The RenovoCath™ RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. The RenovoCath™ RC120 is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath™ RC120 is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vessels ranging between 4mm to 11mm in diameter. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the respective agent manufacturer. The RenovoCath™ RC120 Catheter is not intended for use in coronary and intracranial arteries. The RenovoCath™ RC120 Catheter is not intended for embolic protection or as an aspiration catheter.

Source page: https://510kreport.com/device/K141175
Methodology: https://510kreport.com/methodology