Cardiovascular System Inc

FDA Filings

This page includes the latest FDA filings for Cardiovascular System 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 K151260 Cardiovascular System, Inc.	ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD	2015-06-10

Similar & Related FDA Registered Companies

• CARDIOVASCULAR SYSTEMS INCORPORATED
• CARDIOVASCULAR IMAGING SYSTEMS, INC.
• 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