FDA 510(k) Application Details - K043401

Device Classification Name	Stylet, Catheter   More FDA Info for this Device
510(K) Number	K043401
Device Name	Stylet, Catheter
Applicant	SPECTRANETICS CORP. 96 TALAMINE CT. COLORADO SPRINGS, CO 80907-5159 US Other 510(k) Applications for this Company
Contact	MICHAEL J RYAN Other 510(k) Applications for this Contact
Regulation Number	870.1380   More FDA Info for this Regulation Number
Classification Product Code	DRB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/10/2004
Decision Date	03/16/2005
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