FDA 510(k) Application Details - K122590

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K122590
Device Name	Wire, Guide, Catheter
Applicant	Terumo Medical Corporation 265 DAVIDSON AVE, STE 320 SOMERSET, NJ 08873 US Other 510(k) Applications for this Company
Contact	STACY A KLUESNER, MS, RAC 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	08/24/2012
Decision Date	03/01/2013
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