FDA 510(k) Application Details - K170831

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K170831
Device Name	Introducer, Catheter
Applicant	EpiEP, INc 195 Church Street, 17th Floor New Haven, CT 06510 US Other 510(k) Applications for this Company
Contact	Pamela Bunes Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2017
Decision Date	05/09/2017
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