Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K093160 |
Device Name |
HEADWAY 21 MICROCATHETER, MODEL: MC212150S |
Applicant |
MICROVENTION, INC. |
1311 VALENCIA AVE |
TUSTIN,
CA
92780
|
|
Applicant Contact |
Naomi Gong |
Correspondent |
MICROVENTION, INC. |
1311 VALENCIA AVE |
TUSTIN,
CA
92780
|
|
Correspondent Contact |
Naomi Gong |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 10/06/2009 |
Decision Date | 11/05/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|