FDA 510(k) Application Details - K203487

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K203487
Device Name	Catheter, Intravascular, Diagnostic
Applicant	Accurate Medical Therapeutics Ltd 19 Eli Hurvitz Street Rehovot 7608802 IL Other 510(k) Applications for this Company
Contact	Osnat Harbater Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2020
Decision Date	12/11/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review