FDA 510(k) Application Details - K161208

Device Classification Name	More FDA Info for this Device
510(K) Number	K161208
Device Name	CROSSER CTO Recanalization Catheter
Applicant	Bard Peripheral Vacular, Inc. 1625 West 3rd Street Tempe, AZ 85281 US Other 510(k) Applications for this Company
Contact	Melanie Hadlock Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2016
Decision Date	05/24/2016
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