Device Classification Name |
Device, Neurovascular Embolization
|
510(k) Number |
K993417 |
Device Name |
GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE 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 |
|
Subsequent Product Code |
|
Date Received | 10/01/1999 |
Decision Date | 01/21/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|