Cardio Systems Inc

FDA Filings

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

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K131092 CARDIO SYSTEMS, INC.	STEALTH 360 ORBITAL PAD SYSTEM	2013-06-24
PMN K081944 CARDIO SYSTEMS, INC.	MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM	2008-08-14
PMN K972022 CARDIO SYSTEMS, INC.	ZAK-2000	1998-01-22
PMN K934689 CARDIO SYSTEMS, INC.	LOW AIR LOSS MATTRESS, MODIFICATION	1994-02-02
PMN K921500 CARDIO SYSTEMS, INC.	CENTRI-SAFE(TM) VALVE	1992-09-15
PMN K882177 CARDIO SYSTEMS, INC.	ADD-ON TO CRITICAL PATIENT CARE BED	1988-12-01
PMN K852736 CARDIO SYSTEMS, INC.	BAYLOR RAPID AUTOTRANSFUSION SYSTEM	1985-09-18
PMN K792152 CARDIO SYSTEMS, INC.	CARDIOPLEGIA SOLUTION ADMIN. SET	1979-11-13
PMN K792151 CARDIO SYSTEMS, INC.	OXYGENATOR GAS LINE FILTER	1979-11-13

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• CARDIOVASCULAR SYSTEMS, INC.651 Campus Drminneapolis, MN 55211 PMA NumberP130005 Supplement NumberS035 Date Received02/18/2022 Decision Date03/11/2022 Product Code MCX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	0AJN0	CARDIO SYSTEMS INC
CAGE Code	0AJN0	CARDIO SYSTEMS INC