FDA 510(k) Application Details - K052844

Device Classification Name	Catheter, Intravascular Occluding, Temporary   More FDA Info for this Device
510(K) Number	K052844
Device Name	Catheter, Intravascular Occluding, Temporary
Applicant	RICHTER & ROTHE AG WILHELM LEUSCHNER PLATZ 12 LEIPZIG 04107 DE Other 510(k) Applications for this Company
Contact	JOACHIM RICHTER Other 510(k) Applications for this Contact
Regulation Number	870.4450   More FDA Info for this Regulation Number
Classification Product Code	MJN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/2005
Decision Date	03/20/2006
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