Device Classification Name |
introducer, catheter
|
510(k) Number |
K070417 |
Device Name |
ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 |
Applicant |
ST. JUDE MEDICAL |
14901 DEVEAU PL. |
MINNETONKA,
MN
55345 -2126
|
|
Applicant Contact |
Laura Moen-Ftacek |
Correspondent |
ST. JUDE MEDICAL |
14901 DEVEAU PL. |
MINNETONKA,
MN
55345 -2126
|
|
Correspondent Contact |
Laura Moen-Ftacek |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 02/12/2007 |
Decision Date | 06/05/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|