RenovoCath

Catheter, Intravascular Occluding, Temporary

RenovoRx, Inc.

The following data is part of a premarket notification filed by Renovorx, Inc. with the FDA for Renovocath.

Pre-market Notification Details

• Device ID: K191606
• 510k Number: K191606
• Device Name: RenovoCath
• Classification: Catheter, Intravascular Occluding, Temporary
• Applicant: RenovoRx, Inc. 4546 El Camino Real, Suite 223 Los Altos, CA 94022
• Contact: Kamran Najmabadi
• Correspondent: Debra Cogan; RenovoRx, Inc. 4546 El Camino Real, Suite 223 Los Altos, CA 94022
• Product Code: MJN
• CFR Regulation Number: 870.4450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-06-17
• Decision Date: 2019-08-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00851994005003	K191606	000