Device Classification Name |
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
|
510(k) Number |
K121532 |
Device Name |
HERO GRAFT |
Applicant |
HEMOSPHERE INC |
6545 CITY WEST PARKWAY |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
LAURIE LYNCH |
Correspondent |
HEMOSPHERE INC |
6545 CITY WEST PARKWAY |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
LAURIE LYNCH |
Regulation Number | 870.3450
|
Classification Product Code |
|
Date Received | 05/24/2012 |
Decision Date | 06/22/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|