Device Classification Name |
trocar
|
510(k) Number |
K122587 |
Device Name |
BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 |
Applicant |
ST. JUDE MEDICAL |
14901 DEVEAU PL. |
MINNETONKA,
MN
55345 -2126
|
|
Applicant Contact |
HARLAN JONES |
Correspondent |
ST. JUDE MEDICAL |
14901 DEVEAU PL. |
MINNETONKA,
MN
55345 -2126
|
|
Correspondent Contact |
HARLAN JONES |
Regulation Number | 870.1390
|
Classification Product Code |
|
Date Received | 08/24/2012 |
Decision Date | 02/07/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|