Device Classification Name |
Device, Neurovascular Embolization
|
510(k) Number |
K091641 |
FOIA Releasable 510(k) |
K091641
|
Device Name |
HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT) |
Applicant |
MICROVENTION, INC. |
75 COLUMBIA |
SUITE A |
ALISO VIEJO,
CA
92656 -1408
|
|
Applicant Contact |
Naomi Gong |
Correspondent |
MICROVENTION, INC. |
75 COLUMBIA |
SUITE A |
ALISO VIEJO,
CA
92656 -1408
|
|
Correspondent Contact |
Naomi Gong |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 06/04/2009 |
Decision Date | 06/30/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|