FDA 510(k) Application Details - K121859

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K121859
Device Name	Catheter, Percutaneous
Applicant	NUMED, INC. 2880 MAIN ST. HOPKINTON, NY 12965 US Other 510(k) Applications for this Company
Contact	NICHELLE LAFLESH 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	06/26/2012
Decision Date	08/31/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review