Device Classification Name |
catheter for crossing total occlusions
|
510(k) Number |
K101777 |
Device Name |
PIONEER PLUS CATHETER, MODEL PLUS 120 |
Applicant |
MEDTRONIC VASCULAR |
3576 Unocal Place |
Santa Rosa,
CA
95403
|
|
Applicant Contact |
LUCINDA L FOX |
Correspondent |
MEDTRONIC VASCULAR |
3576 Unocal Place |
Santa Rosa,
CA
95403
|
|
Correspondent Contact |
LUCINDA L FOX |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/25/2010 |
Decision Date | 07/23/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|