# K160067: RenovoCath

- Pathway: 510(k) (Traditional)
- Applicant: Renovorx, Inc.
- Decided: Mar 7, 2017 after 419 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 K021721 (2002). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140273: Equalizer Occlusion Balloon Catheter, Boston Scientific Corp (2014) Summary page 4.

## Most influential descendants
- K191606: RenovoCath (2019), 1 descendant of its own
- K212324: RenovoCath (2021), 0 descendants of its own

## 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 also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. 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/K160067
Methodology: https://510kreport.com/methodology