Device Classification Name |
Device, Neurovascular Embolization
|
510(k) Number |
K001083 |
Device Name |
GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4 |
Applicant |
BOSTON SCIENTIFIC, TARGET |
47900 BAYSIDE PKWY. |
FREMONT,
CA
94538
|
|
Applicant Contact |
JAMES LEATHLEY |
Correspondent |
BOSTON SCIENTIFIC, TARGET |
47900 BAYSIDE PKWY. |
FREMONT,
CA
94538
|
|
Correspondent Contact |
JAMES LEATHLEY |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 04/04/2000 |
Decision Date | 05/03/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|