FDA 510(k) Application Details - K180023

Device Classification Name	Temporary Carotid Catheter For Embolic Capture   More FDA Info for this Device
510(K) Number	K180023
Device Name	Temporary Carotid Catheter For Embolic Capture
Applicant	Gardia Medical Ltd. HaEshel 2 Caesarea 3088900 IL Other 510(k) Applications for this Company
Contact	Vardit Segal Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	NTE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/03/2018
Decision Date	03/21/2018
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