Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K191237 |
Device Name |
CERENOVUS Large Bore Catheter |
Applicant |
Codman & Shurtleff, Inc. |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Applicant Contact |
Kirsten Franco |
Correspondent |
Codman & Shurtleff, Inc. |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Correspondent Contact |
Kirsten Franco |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 05/08/2019 |
Decision Date | 11/08/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|