FDA 510(k) Application Details - K251485

Device Classification Name	More FDA Info for this Device
510(K) Number	K251485
Device Name	Excipio LV Prime Thrombectomy Device
Applicant	Contego Medical, Inc. 3801 Lake Boone Trail Suite 100 Raleigh, NC 27607 US Other 510(k) Applications for this Company
Contact	Nitin Mehta 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	05/14/2025
Decision Date	06/13/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review