Device Classification Name |
Device, Neurovascular Embolization
|
510(k) Number |
K042297 |
Device Name |
ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES |
Applicant |
ACTA VASCULAR SYSTEMS, INC. |
247 MARCHMONT DR. |
LOS GATOS,
CA
95032
|
|
Applicant Contact |
RICHARD M RUEDY |
Correspondent |
ACTA VASCULAR SYSTEMS, INC. |
247 MARCHMONT DR. |
LOS GATOS,
CA
95032
|
|
Correspondent Contact |
RICHARD M RUEDY |
Regulation Number | 882.5950
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/24/2004 |
Decision Date | 06/01/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|