FDA 510(k) Application Details - K222185

Device Classification Name	More FDA Info for this Device
510(K) Number	K222185
Device Name	Stratus Infusion Catheter
Applicant	InterVene, Inc. 415 Grand Avenue, Suite 302 South San Francisco, CA 94080 US Other 510(k) Applications for this Company
Contact	Jeff Elkins Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	NPG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/2022
Decision Date	04/13/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review