FDA 510(k) Application Details - K052296

Device Classification Name	More FDA Info for this Device
510(K) Number	K052296
Device Name	CLIRPATH TURBO EXCIMER LASER CATHETERS
Applicant	SPECTRANETICS CORP. 96 TALAMINE CT. COLORADO SPRINGS, CO 80907-5159 US Other 510(k) Applications for this Company
Contact	NEIL BURRIS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2005
Decision Date	09/02/2005
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