Device Classification Name |
catheter, peripheral, atherectomy
|
510(k) Number |
K152181 |
Device Name |
Turbo-Power Laser Atherectomy Catheter |
Applicant |
SPECTRANETICS, INC. |
9965 FEDERAL DRIVE |
COLORADO SPRINGS,
CO
80921
|
|
Applicant Contact |
Priscila Tapia |
Correspondent |
SPECTRANETICS, INC. |
9965 FEDERAL DRIVE |
COLORADO SPRINGS,
CO
80921
|
|
Correspondent Contact |
Priscila Tapia |
Regulation Number | 870.4875
|
Classification Product Code |
|
Date Received | 08/04/2015 |
Decision Date | 11/12/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|