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
|
|
|