Device Classification Name |
catheter, peripheral, atherectomy
|
510(k) Number |
K222837 |
Device Name |
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters |
Applicant |
Spectranetics Inc. |
9965 Federal Drive |
Colorado Springs,
CO
80921
|
|
Applicant Contact |
Taylor Olen |
Correspondent |
Spectranetics Inc. |
9965 Federal Drive |
Colorado Springs,
CO
80921
|
|
Correspondent Contact |
Taylor Olen |
Regulation Number | 870.4875
|
Classification Product Code |
|
Date Received | 09/20/2022 |
Decision Date | 12/08/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|