Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K033540 |
Device Name |
TRANSXCHANGE SUPPORT CATHETER |
Applicant |
MEDTRONIC VASCULAR |
3576 Unocal Place |
Santa Rosa,
CA
95403
|
|
Applicant Contact |
LEISA MARTINEZ |
Correspondent |
MEDTRONIC VASCULAR |
3576 Unocal Place |
Santa Rosa,
CA
95403
|
|
Correspondent Contact |
LEISA MARTINEZ |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 11/10/2003 |
Decision Date | 05/25/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|