FDA 510(k) Application Details - K070970

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K070970
Device Name	Catheter, Percutaneous
Applicant	PENUMBRA, INC. 2401 MERCED ST., SUITE 200 SAN LEANDRO, CA 94577 US Other 510(k) Applications for this Company
Contact	THERESA BRANDNER-ALLEN Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2007
Decision Date	08/17/2007
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