Device Classification Name |
catheter for crossing total occlusions
|
510(k) Number |
K071227 |
Device Name |
CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15 |
Applicant |
SPECTRANETICS CORP. |
96 TALAMINE CT. |
COLORADO SPRINGS,
CO
80907 -5159
|
|
Applicant Contact |
MICHAEL K HANDLEY |
Correspondent |
SPECTRANETICS CORP. |
96 TALAMINE CT. |
COLORADO SPRINGS,
CO
80907 -5159
|
|
Correspondent Contact |
MICHAEL K HANDLEY |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 05/03/2007 |
Decision Date | 07/11/2007 |
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
|
|
|