Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K073200 |
Device Name |
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582 |
Applicant |
VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT |
MINNEAPOLIS,
MN
55369
|
|
Applicant Contact |
JULIE TAPPER |
Correspondent |
VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT |
MINNEAPOLIS,
MN
55369
|
|
Correspondent Contact |
JULIE TAPPER |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 11/13/2007 |
Decision Date | 02/01/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|