Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K180864 |
Device Name |
WATCHMAN TruSeal Access System |
Applicant |
Boston Scientific |
Three Scimed Place |
Maple Grove,
MN
55311 -1566
|
|
Applicant Contact |
Nikki M Ibis |
Correspondent |
Boston Scientific |
Three Scimed Place |
Maple Grove,
MN
55311 -1566
|
|
Correspondent Contact |
Nikki M Ibis |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 04/02/2018 |
Decision Date | 07/20/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|