FDA 510(k) Application Details - K233909

Device Classification Name	More FDA Info for this Device
510(K) Number	K233909
Device Name	CleanerÖ Plus 18F Thrombectomy System - CleanerÖ Plus 18F Aspiration Catheter, CleanerÖ Plus 18F Handpiece with Maceration Wire, CleanerÖ Plus 18F Aspiration Canister
Applicant	Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 US Other 510(k) Applications for this Company
Contact	Ana Jimenez-Hughes 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	12/12/2023
Decision Date	03/28/2024
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