Device Classification Name |
device, neurovascular embolization
|
510(k) Number |
K031049 |
Device Name |
GUGLIELMI DETACHABLE COIL (GDC) |
Applicant |
BOSTON SCIENTIFIC, TARGET |
47900 BAYSIDE PKWY. |
FREMONT,
CA
94538
|
|
Applicant Contact |
ROXANE BAXTER |
Correspondent |
BOSTON SCIENTIFIC, TARGET |
47900 BAYSIDE PKWY. |
FREMONT,
CA
94538
|
|
Correspondent Contact |
ROXANE BAXTER |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 04/02/2003 |
Decision Date | 08/01/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|