FDA 510(k) Application Details - K223891

Device Classification Name	More FDA Info for this Device
510(K) Number	K223891
Device Name	Cobra Catheter System
Applicant	Endovascular Engineering 3925 Bohannon Drive, Suite 300 Menlo Park, CA 94025 US Other 510(k) Applications for this Company
Contact	Debra Cogan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2022
Decision Date	02/15/2023
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