FDA 510(k) Application Details - K213565

Device Classification Name	More FDA Info for this Device
510(K) Number	K213565
Device Name	JETi AIO Peripheral Thrombectomy System
Applicant	Walk Vascular, LLC 17171 Daimler Street Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Namratha Manthani Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2021
Decision Date	02/01/2022
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