Device Classification Name |
Device, Neurovascular Embolization
|
510(k) Number |
K871047 |
Device Name |
RADIOPAQUE SPHERICAL EMBOLI (RSE) |
Applicant |
INTERVENTIONAL THERAPEUTICS CORP. |
664 SOUTH SAN MARCOS RD. |
SANTA BARBARA,
CA
93111
|
|
Applicant Contact |
JULIE D BELL |
Correspondent |
INTERVENTIONAL THERAPEUTICS CORP. |
664 SOUTH SAN MARCOS RD. |
SANTA BARBARA,
CA
93111
|
|
Correspondent Contact |
JULIE D BELL |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 03/17/1987 |
Decision Date | 05/22/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|