FDA 510(k) Application Details - K162418

Device Classification Name	More FDA Info for this Device
510(K) Number	K162418
Device Name	Pioneer Plus Catheter
Applicant	PHILIPS VOLCANO 3721 VALLEY CENTRE DR, SUITE 500 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	MARY STANNERS 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	08/30/2016
Decision Date	12/02/2016
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