Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011279674

FEI Number

3011279674

Entity Name

RENOVORX, INC.

City/State/Country

Mountain View, CA, US

Establishment Address

2570 W El Camino, Suite 320, Mountain View, CA 94040, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

RenovoRx, Inc. (Owner Number: 10047877)

Owner / Operator Contact Address

2570 W. El Camino Real, Suite 640, Mountain View, CA 94040, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212324

PMA Number

N/A

All Registered Proprietary Names

RenovoCath

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2021-12-30

Official Correspondent

Robert Strasser

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RenovoRx, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051067	LeMaitre Vascular, Inc.	PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)	2005-05-27
K093847	Thermopeutix, Inc.	DUFLO CATHETER (HEPARIN COATED)	2010-08-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2009	Edwards Lifesciences, LLC	2	Edwards Lifesciences*Fogarty Fortis*Arterial Embolectomy Catheter Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.

Similar Registrations

Registration Number	Establishment Name	Location
9616684	Boston Scientific Limited	CORK Munster, IE
9681260	Boston Scientific Limited	GALWAY, IE
3012179728	St. Jude Medical	Roseville, MN, US
3012279212	PRYTIME MEDICAL DEVICES, INC.	Lakewood, CO, US
3015550451	MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011279674. Last updated year: 2026. Please use registration number 3011279674 when referencing this establishment in official correspondence.