The following data is part of a premarket notification filed by Renovorx, Inc. with the FDA for Renovocath.
Device ID | K160067 |
510k Number | K160067 |
Device Name: | RenovoCath |
Classification | Catheter, Intravascular Occluding, Temporary |
Applicant | RenovoRx, Inc. 4546 El Camino Real, Suite 282 Los Altos, CA 94022 |
Contact | Kamran Najmabadi |
Correspondent | Ronald S. Warren Experien Group, LLC 755 N. Mathilda Avenue 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 | 2016-01-13 |
Decision Date | 2017-03-07 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RENOVOCATH 85956593 4689326 Live/Registered |
Renovorx 2013-06-11 |