FDA 510(k) Application Details - K080700

Device Classification Name	Catheter, Intravascular Occluding, Temporary   More FDA Info for this Device
510(K) Number	K080700
Device Name	Catheter, Intravascular Occluding, Temporary
Applicant	THERMOPEUTIX INC. 9925B BUSINESS PARK AVE. SAN DIEGO, CA 92131 US Other 510(k) Applications for this Company
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	03/11/2008
Decision Date	09/26/2008
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	Y
Expedited Review