Device Classification Name |
Tubes, Vials, Systems, Serum Separators, Blood Collection
|
510(k) Number |
K142946 |
Device Name |
TIVA |
Applicant |
Velano Vascular, Inc. |
1500 Locust St Suite 4311 |
Philadelphia,
PA
19102
|
|
Applicant Contact |
Tiffini Diage |
Correspondent |
Velano Vascular, Inc. |
1500 Locust St Suite 4311 |
Philadelphia,
PA
19102
|
|
Correspondent Contact |
Tiffini Diage |
Regulation Number | 862.1675 |
Classification Product Code |
|
Date Received | 10/10/2014 |
Decision Date | 01/08/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|