FDA 510(k) Application Details - K243549

Device Classification Name	More FDA Info for this Device
510(K) Number	K243549
Device Name	JETi Hydrodynamic Thrombectomy System
Applicant	Abbott Medical 3200 Lakeside Drive Santa Clara, CA 95054 US Other 510(k) Applications for this Company
Contact	Fiona Pu 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	11/15/2024
Decision Date	04/04/2025
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