The following data is part of a premarket notification filed by Renovorx, Inc. with the FDA for Renovocath Rc120.
| Device ID | K141175 |
| 510k Number | K141175 |
| Device Name: | RENOVOCATH RC120 |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | RENOVORX, INC. 755 N. MATHILDA AVE, STE 100 Sunnyvale, CA 94085 |
| Contact | Ron S Warren |
| Correspondent | Ron S Warren RENOVORX, INC. 755 N. MATHILDA AVE, STE 100 Sunnyvale, CA 94085 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-06 |
| Decision Date | 2014-10-24 |
| Summary: | summary |