Device Classification Name |
Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
More FDA Info for this Device |
510(K) Number |
K211134 |
Device Name |
Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon |
Applicant |
NuMED, Inc
2880 Main Street
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 |
04/16/2021 |
Decision Date |
05/27/2021 |
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 |
|