FDA 510(k) Application Details - K213657

Device Classification Name	More FDA Info for this Device
510(K) Number	K213657
Device Name	DEEPVESSEL FFR
Applicant	KeyaMed NA Inc. 107 Spring Street Seattle, WA 98104 US Other 510(k) Applications for this Company
Contact	Xiaoxiao Liu Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PJA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2021
Decision Date	04/01/2022
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