Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K240018 |
Device Name |
WATCHMAN TruSteer Access System (M635TU90050) |
Applicant |
Boston Scientific Corporation |
300 Boston Scientific Way |
Marlborough,
MA
01752 -1234
|
|
Applicant Contact |
Alexa Keenan |
Correspondent |
Boston Scientific Corporation |
300 Boston Scientific Way |
Marlborough,
MA
01752 -1234
|
|
Correspondent Contact |
Alexa Keenan |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 01/02/2024 |
Decision Date | 02/01/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|