FDA 510(k) Application Details - K160747

Device Classification Name	More FDA Info for this Device
510(K) Number	K160747
Device Name	Angel Catheter
Applicant	BIO2 MEDICAL, INC. 4670 TABLE MOUNTAIN DRIVE GOLDEN, CO 80403 US Other 510(k) Applications for this Company
Contact	CHRISTOPHER E. BANAS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2016
Decision Date	07/28/2016
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