Device Classification Name |
Clip, Aneurysm
|
510(k) Number |
K983758 |
Device Name |
YASARGIL TITANIUM ANEURYSM CLIPS |
Applicant |
AESCULAP, INC. |
1000 GATEWAY BLVD. |
SOUTH SAN FRANCISCO,
CA
94080
|
|
Applicant Contact |
VICTORIA MACKINNON |
Correspondent |
AESCULAP, INC. |
1000 GATEWAY BLVD. |
SOUTH SAN FRANCISCO,
CA
94080
|
|
Correspondent Contact |
VICTORIA MACKINNON |
Regulation Number | 882.5200
|
Classification Product Code |
|
Date Received | 10/26/1998 |
Decision Date | 12/18/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|