Therox Inc

FDA Filings

This page includes the latest FDA filings for Therox Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 2030964
• FEI Number: 3000719308
• Name: THEROX INC.
• Owner & Operator: TherOx Inc.
• Contact Address: 17500 Cartwright Rd ; Irvine CA 92614 US
• Official Correspondent:
  • Jeffrey Creech
  • x-949-7571999-587
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 17500 Cartwright Rd ; Irvine, CA 92614 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMA P170027S006 TherOx, Inc.	TherOx DownStream System	2021-12-09
PMA P170027S005 TherOx, Inc.	TherOx Downstream System	2021-06-01
PMA P170027S004 TherOx, Inc.	TherOx Downstream System	2021-03-29
PMA P170027S003 TherOx, Inc.	TherOx Downstream System	2021-03-26
PMA P170027S002 TherOx, Inc.	TherOx Downstream System	2020-03-11
GUDID 20862478000463 THEROX, INC.	SSO2 Catheter	2019-08-16
GUDID 20862478000456 THEROX, INC.	SSO2 Catheter	2019-08-16
GUDID 20862478000449 THEROX, INC.	SSO2 Catheter	2019-08-16
GUDID 20862478000432 THEROX, INC.	SSO2 Catheter	2019-08-16
GUDID 10862478000428 THEROX, INC.	DownStream Cartridge	2019-08-16
GUDID 00862478000414 THEROX, INC.	DownStream System	2019-08-16
GUDID 00862478000407 THEROX, INC.	DownStream System	2019-08-16
PMN P170027 | MWG THEROX INC.	TherOx DownStream System	2019-04-10
PMA P170027 TherOx, Inc.	TherOx Downstream System	2019-04-02
PMN K052637 THEROX, INC.	THEROX INFUSION CATHETER, MODEL INCA-1	2006-03-08
PMN K971719 THEROX, INC.	THEROX INFUSION GUIDEWIRES	1997-11-03

Similar & Related FDA Registered Companies

• TherOx, Inc.17500 Cartwright Rdsuite 100irvine, CA 92614-5846 PMA NumberP170027 Supplement NumberS010 Date Received09/30/2022 Decision Date10/27/2022 Product Code MWG  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• TherOx, Inc.17500 Cartwright Rdsuite 100irvine, CA 92614-5846 PMA NumberP170027 Supplement NumberS009 Date Received12/17/2021 Decision Date03/10/2022 Product Code MWG  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	1WS92	THEROX INC.
CAGE Code	1WS92	THEROX INC.
SEC	0001124955	THEROX INC
SEC	0001442217	TherOx, Inc. of DELAWARE