FDA 510(k) Application Details - K133396

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K133396
Device Name	Wire, Guide, Catheter
Applicant	STEREOTAXIS, INC. 4320 FOREST PARK AVENUE SUITE 100 ST. LOUIS, MO 63108 US Other 510(k) Applications for this Company
Contact	DIANE HORWITZ, PH.D. 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	11/06/2013
Decision Date	02/06/2014
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