Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K070238 |
Device Name |
AMPLATZER RELIANT CATHETER DELIVERY SYSTEM |
Applicant |
AGA MEDICAL CORP. |
682 MENDELSSOHN AVE. |
PLYMOUTH,
MN
55427
|
|
Applicant Contact |
DAVID D COX |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 01/25/2007 |
Decision Date | 02/28/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|