FDA 510(k) Application Details - K153488

Device Classification Name	More FDA Info for this Device
510(K) Number	K153488
Device Name	Occlusion Perfusion Catheter
Applicant	Advanced Catheter Therapies, Inc. 25 E. Main Street, Suite 205 Chattanooga, TN 37408 US Other 510(k) Applications for this Company
Contact	Paul Joseph Fitzpatrick Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2015
Decision Date	02/25/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review