FDA 510(k) Application Details - K151896

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K151896
Device Name	Catheter, Percutaneous
Applicant	Cruzar Medsystems, Inc. 50 Braintree Hill Office Park, Suite 301 Braintree, MA 02184 US Other 510(k) Applications for this Company
Contact	Tom Kramer Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/10/2015
Decision Date	12/07/2015
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