FDA 510(k) Application Details - K152497

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K152497
Device Name	Wire, Guide, Catheter
Applicant	TATARA VASCULAR, LLC. 10000 CEDAR AVE CLEVELAND, OH 44106 US Other 510(k) Applications for this Company
Contact	KELLY EMERTON Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/2015
Decision Date	01/22/2016
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