FDA 510(k) Application Details - DEN080015

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN080015
Device Name	NUCLEUS-X PTV CATHETER
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	More FDA Info for this Regulation Number
Classification Product Code	OZT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/24/2008
Decision Date	06/11/2012
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review