FDA 510(k) Application Details - K181372

Device Classification Name	Computer, Diagnostic, Pre-Programmed, Single-Function   More FDA Info for this Device
510(K) Number	K181372
Device Name	Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant	Retia Medical, LLC 7 Dana Rd. Suite 111 Valhalla, NY 10595 US Other 510(k) Applications for this Company
Contact	Marc Zemel Other 510(k) Applications for this Contact
Regulation Number	870.1435   More FDA Info for this Regulation Number
Classification Product Code	DXG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/2018
Decision Date	12/13/2018
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