FDA 510(k) Application Details - K062084

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K062084
Device Name	Catheter, Percutaneous
Applicant	ACUMEN MEDICAL, INC. 275 SANTA ANA COURT SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	Marybeth Gamber 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	07/21/2006
Decision Date	08/18/2006
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