Device Classification Name |
Catheter, Peripheral, Atherectomy
|
510(k) Number |
K140775 |
Device Name |
TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM |
Applicant |
SPECTRANETICS CORPORATION |
9965 FEDERAL DRIVE |
COLORADO SPRINGS,
CO
80921 -3617
|
|
Applicant Contact |
AMANDA JOHNSON |
Correspondent |
SPECTRANETICS CORPORATION |
9965 FEDERAL DRIVE |
COLORADO SPRINGS,
CO
80921 -3617
|
|
Correspondent Contact |
AMANDA JOHNSON |
Regulation Number | 870.4875
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/28/2014 |
Decision Date | 07/23/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01330628
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|