RenovoRx, Inc.
Mountain View, CA, US
RENOVORX, INC. appears in FDA device records in Mountain View, CA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for RenovoRx, Inc. between 2014 and 2021. The busiest year on record is 2014, with 1. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2021 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011279674 | 3011279674 | RENOVORX, INC. | 2570 W El Camino, Mountain View, CA 94040 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0565-2016 | 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. | Incorrect version of Instructions for Use were shipped to two US customers. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain