Cardiovascular Systems, Inc. FDA Approvals

0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System510(k)Mar 1, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Mar 1, 2022
ViperCross Support Catheters510(k)Sep 24, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Sep 24, 2021
Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system510(k)Sep 14, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Sep 14, 2021
ViperCross Support Catheters510(k)Aug 26, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 26, 2021
ViperCath XC Peripheral Exchange Catheter510(k)May 26, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	May 26, 2021
WIRION Embolic Protection System510(k)Mar 3, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Mar 3, 2021