FDA 510(k) Application Details - K223897

Device Classification Name	More FDA Info for this Device
510(K) Number	K223897
Device Name	Excipio LV Thrombectomy Device
Applicant	Contego Medical Inc. 3801 Lake Boone Trail, Suite 100 Raleigh, NC 27607 US Other 510(k) Applications for this Company
Contact	Jim Clossick 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	12/28/2022
Decision Date	02/17/2023
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