Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K101776 |
Device Name |
SCOUTPRO ACS |
Applicant |
BIOTRONIK, INC. |
6024 JEAN ROAD |
LAKE OSWEGO,
OR
97035
|
|
Applicant Contact |
Jon Brumbaugh |
Correspondent |
BIOTRONIK, INC. |
6024 JEAN ROAD |
LAKE OSWEGO,
OR
97035
|
|
Correspondent Contact |
Jon Brumbaugh |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/25/2010 |
Decision Date | 07/23/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|