Data / Medical devices / United States / Renovorx, Inc.
Renovorx, Inc.: FDA-registered device maker in Mountain View, CA, United States, 2 510(k) clearances
Renovorx, Inc. is registered with the FDA (registration 3011279674) in Mountain View, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 23, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011279674
- Address
- 2570 W El Camino Suite 320, Mountain View, CA, United States, 94040
- Owner or operator
- RenovoRx, Inc. (10047877)
- Roles
- Specification developer
- First device listed
- December 30, 2021
- Registered through
- 2026
- Brand names listed
- RenovoCath
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular Occluding, Temporary | MJN | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 23, 2021 | K212324 | RenovoCath | MJN | Substantially Equivalent | Renovorx, Inc. | accessdata.fda.gov |
| August 7, 2019 | K191606 | RenovoCath | MJN | Substantially Equivalent | Renovorx, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 25, 2015 | 72810 | Class II | Terminated | 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, incl | Incorrect version of Instructions for Use were shipped to two US customers. | accessdata.fda.gov |
Compare with other makers
Updated August 23, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.