Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K022138 |
Device Name |
SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 |
Applicant |
SPECTRANETICS CORP. |
96 TALAMINE CT. |
COLORADO SPRINGS,
CO
80907 -5159
|
|
Applicant Contact |
MICHAEL J RYAN |
Correspondent |
SPECTRANETICS CORP. |
96 TALAMINE CT. |
COLORADO SPRINGS,
CO
80907 -5159
|
|
Correspondent Contact |
MICHAEL J RYAN |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 07/02/2002 |
Decision Date | 09/23/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|