Device Classification Name |
device, vascular, for promoting embolization
|
510(k) Number |
K133282 |
Device Name |
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM |
Applicant |
REVERSE MEDICAL CORPORATION |
13700 Alton Parkway |
Suite 167 |
Irvine,
CA
92618
|
|
Applicant Contact |
JEFFREY VALKO |
Correspondent |
REVERSE MEDICAL CORPORATION |
13700 Alton Parkway |
Suite 167 |
Irvine,
CA
92618
|
|
Correspondent Contact |
JEFFREY VALKO |
Regulation Number | 870.3300
|
Classification Product Code |
|
Date Received | 10/25/2013 |
Decision Date | 11/27/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|