Device Classification Name |
catheter for crossing total occlusions
|
510(k) Number |
K081804 |
Device Name |
PIONEER PLUS CATHETER |
Applicant |
MEDTRONIC INC. |
3576 Unocal Place |
Santa Rosa,
CA
95403
|
|
Applicant Contact |
CATHERINE PRIESTLEY |
Correspondent |
MEDTRONIC INC. |
3576 Unocal Place |
Santa Rosa,
CA
95403
|
|
Correspondent Contact |
CATHERINE PRIESTLEY |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/26/2008 |
Decision Date | 08/05/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|