Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K033678 |
Device Name |
SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038 |
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 | 11/24/2003 |
Decision Date | 02/23/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|