Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K101885 |
Device Name |
MEDTRONIC C315 DELIVERY CATHETER |
Applicant |
MEDTRONIC INC. |
8200 CORAL SEA STREET NE |
MS MV S11 |
MOUNDS VIEW,
MN
55112
|
|
Applicant Contact |
BRUCE BACKLUND |
Correspondent |
MEDTRONIC INC. |
8200 CORAL SEA STREET NE |
MS MV S11 |
MOUNDS VIEW,
MN
55112
|
|
Correspondent Contact |
BRUCE BACKLUND |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 07/06/2010 |
Decision Date | 09/09/2010 |
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
|
|
|