FDA 510(k) Application Details - K051515

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K051515
Device Name	Introducer, Catheter
Applicant	ACUMEN MEDICAL, INC. 1400 TERRA BELLA BLVD. SUITE A MOUNTAIN VIEW, CA 94043 US Other 510(k) Applications for this Company
Contact	Marybeth Gamber Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/2005
Decision Date	09/01/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review