Device Classification Name |
balloon aortic valvuloplasty
|
510(k) Number |
K133607 |
Device Name |
V8 TRANSLUMINAL BAV CATHETER |
Applicant |
INTERVALVE, INC |
8401 73RD AVENUE NORTH, STE 63 |
MINNEAPOLIS,
MN
55428
|
|
Applicant Contact |
JULIE BODMER |
Correspondent |
INTERVALVE, INC |
8401 73RD AVENUE NORTH, STE 63 |
MINNEAPOLIS,
MN
55428
|
|
Correspondent Contact |
JULIE BODMER |
Regulation Number | 870.1255
|
Classification Product Code |
|
Date Received | 11/25/2013 |
Decision Date | 02/11/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|