FDA 510(k) Application Details - K082725

Device Classification Name	Catheter, Irrigation   More FDA Info for this Device
510(K) Number	K082725
Device Name	Catheter, Irrigation
Applicant	MAQUET CARDIOVASCULAR, LLC 170 BAYTECH DRIVE SAN JOSE, CA 95134 US Other 510(k) Applications for this Company
Contact	CHRISTINA L ROWE Other 510(k) Applications for this Contact
Regulation Number	878.4200   More FDA Info for this Regulation Number
Classification Product Code	GBX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/2008
Decision Date	12/17/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review