Device Classification Name |
laser-powered inferior vena cava filter retrieval catheter
|
De Novo Number |
DEN210024 |
Device Name |
CavaClear Laser Sheath |
Requester |
spectranetics, inc. |
9965 federal drive |
colorado springs,
CO
80921
|
|
Contact |
sondra chandler |
|
Regulation Number | 870.5125
|
Classification Product Code |
|
Date Received | 06/25/2021 |
Decision Date | 12/21/2021 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Cardiovascular
|
Review Advisory Committee |
Cardiovascular
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|