Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K120212 |
Device Name |
AFX INTRODUCER SYSTEM |
Applicant |
ENDOLOGIX, INC. |
11 STUDEBAKER |
IRVINE,
CA
92610
|
|
Applicant Contact |
Janet M Fauls |
Correspondent |
ENDOLOGIX, INC. |
11 STUDEBAKER |
IRVINE,
CA
92610
|
|
Correspondent Contact |
Janet M Fauls |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 01/24/2012 |
Decision Date | 02/09/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|