Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K021455 |
Device Name |
RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782, |
Applicant |
GUIDANT CORP. |
4100 HAMLINE AVE., NORTH |
ST. PAUL,
MN
55112 -5798
|
|
Applicant Contact |
KAREN S ALSOP |
Correspondent |
GUIDANT CORP. |
4100 HAMLINE AVE., NORTH |
ST. PAUL,
MN
55112 -5798
|
|
Correspondent Contact |
KAREN S ALSOP |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 05/06/2002 |
Decision Date | 08/02/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|