FDA 510(k) Application Details - K211679

Device Classification Name	Dilator, Vessel, For Percutaneous Catheterization   More FDA Info for this Device
510(K) Number	K211679
Device Name	Dilator, Vessel, For Percutaneous Catheterization
Applicant	Xcardia Innovation Ltd. 1 Hamada Street Rehovot 7670301 IL Other 510(k) Applications for this Company
Contact	Benny Rousso Other 510(k) Applications for this Contact
Regulation Number	870.1310   More FDA Info for this Regulation Number
Classification Product Code	DRE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2021
Decision Date	02/17/2022
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