Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K091299 |
Device Name |
SPECTRANETICS TURBO-TANDEM SYSTEM |
Applicant |
SPECTRANETICS CORP. |
9965 Federal Drive |
Colorado Springs,
CO
80921
|
|
Applicant Contact |
GRACIE MURGUIA |
Correspondent |
SPECTRANETICS CORP. |
9965 Federal Drive |
Colorado Springs,
CO
80921
|
|
Correspondent Contact |
GRACIE MURGUIA |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 05/04/2009 |
Decision Date | 07/01/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|