Device Classification Name |
catheter, percutaneous, neurovasculature
|
510(k) Number |
K200910 |
Device Name |
BOSS Balloon Guide Catheter |
Applicant |
Marblehead Medical |
11600 96th Ave N |
maple grove,
MN
55369
|
|
Applicant Contact |
kristin mortenson |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
saint paul,
MN
55114
|
|
Correspondent Contact |
prithul bom |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/06/2020 |
Decision Date | 05/02/2020 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|