FDA 510(k) Application Details - K170664

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K170664
Device Name	Catheter, Percutaneous
Applicant	Heraeus Medical Components, LLC 2605 Fernbrook Lane North, Suite J Plymouth, MN 55447 US Other 510(k) Applications for this Company
Contact	Margaret Batchelder 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	03/06/2017
Decision Date	11/09/2017
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