FDA 510(k) Application Details - K161451

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon   More FDA Info for this Device
510(K) Number	K161451
Device Name	Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
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	NVM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/2016
Decision Date	09/22/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review