FDA-Device2016-01-06Class II
RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: 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.
RenovoRx, Inc.
Hazard
Incorrect version of Instructions for Use were shipped to two US customers.
Sold states
US Distribution to the states of : CA and FL.
Affected count
11 units
Manufactured in
4546 El Camino Real Ste 282, N/A, Los Altos, CA, United States
Products
RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0565-2016Don't want to check this manually?
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