FDA 510(k) Application Details - K221391

Device Classification Name	More FDA Info for this Device
510(K) Number	K221391
Device Name	WOLF ThrombectomyÖ SmartClaw Catheter
Applicant	DeVoro Medical, Inc 46724 Lakeview Blvd Fremont, CA 94358 US Other 510(k) Applications for this Company
Contact	Vanessa Fowler 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	05/13/2022
Decision Date	11/10/2022
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