Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K212228 |
Device Name |
WATCHMAN FXD Curve Access System |
Applicant |
Boston Scientific Corporation |
Three Scimed Place |
Maple Grove,
MN
55311 -1566
|
|
Applicant Contact |
Alexa M. Keenan |
Correspondent |
Boston Scientific Corporation |
Three Scimed Place |
Maple Grove,
MN
55311 -1566
|
|
Correspondent Contact |
Alexa M. Keenan |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 07/16/2021 |
Decision Date | 08/13/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|