FDA 510(k) Application Details - K162322

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K162322
Device Name	Introducer, Catheter
Applicant	ACCESS SCIENTIFIC, LLC 3910 Sorrento Valley Blvd Ste 200 San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	WALTER CORDIGLIA 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	08/19/2016
Decision Date	11/17/2016
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