FDA 510(k) Application Details - K152202

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K152202
Device Name	Catheter, Percutaneous
Applicant	TNI Manufacturing, Inc. 4635 NW 103rd Avenue Sunrise, FL 33351 US Other 510(k) Applications for this Company
Contact	Daniel Sablyak 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	08/06/2015
Decision Date	12/14/2015
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	Y
Expedited Review