FDA 510(k) Application Details - K213915

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon   More FDA Info for this Device
510(K) Number	K213915
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	12/15/2021
Decision Date	01/12/2022
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