Device Classification Name |
device, neurovascular embolization
|
510(k) Number |
K080967 |
Device Name |
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT |
Applicant |
CORDIS NEUROVASCULAR, INC. |
14201 NW 60TH AVENUE |
MIAMI LAKES,
FL
33014
|
|
Applicant Contact |
Amarilys Machado |
Correspondent |
CORDIS NEUROVASCULAR, INC. |
14201 NW 60TH AVENUE |
MIAMI LAKES,
FL
33014
|
|
Correspondent Contact |
Amarilys Machado |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 04/04/2008 |
Decision Date | 05/02/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|