Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K033989 |
Device Name |
MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69 |
Applicant |
MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT |
7000 CENTRAL AVE. N.E. |
MINNEAPOLIS,
MN
55432
|
|
Applicant Contact |
KRISTY K MOLLNER |
Correspondent |
MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT |
7000 CENTRAL AVE. N.E. |
MINNEAPOLIS,
MN
55432
|
|
Correspondent Contact |
KRISTY K MOLLNER |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 12/23/2003 |
Decision Date | 01/22/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|