FDA 510(k) Application Details - K223929

Device Classification Name	More FDA Info for this Device
510(K) Number	K223929
Device Name	LagunaÖ Clot Retriever System and MalibuÖ Aspiration Catheter System (Laguna Thrombectomy System)
Applicant	Innova Vascular, Inc. 15375 Barranca Parkway, B-101 Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Ryan Kenney 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	12/30/2022
Decision Date	06/01/2023
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