Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K000004 |
Device Name |
ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 |
Applicant |
DAIG CORP. |
14901 DEVEAU PLACE |
MINNETONKA,
MN
55345 -2126
|
|
Applicant Contact |
PAUL CORNELISON |
Correspondent |
DAIG CORP. |
14901 DEVEAU PLACE |
MINNETONKA,
MN
55345 -2126
|
|
Correspondent Contact |
PAUL CORNELISON |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 01/03/2000 |
Decision Date | 11/29/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|