FDA 510(k) Application Details - K221902

Device Classification Name	Valvulotome   More FDA Info for this Device
510(K) Number	K221902
Device Name	Valvulotome
Applicant	LimFlow, Inc. 3031 Tisch Way - 110 Plaza West San Jose, CA 95128 US Other 510(k) Applications for this Company
Contact	Zachary Woodson Other 510(k) Applications for this Contact
Regulation Number	870.4885   More FDA Info for this Regulation Number
Classification Product Code	MGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/30/2022
Decision Date	12/21/2022
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