Device Classification Name |
tubes, vials, systems, serum separators, blood collection
|
510(k) Number |
K220258 |
Device Name |
20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) |
Applicant |
AVIA Vascular |
6030 W Harold Gatty Dr. |
Salt Lake City,
UT
84116
|
|
Applicant Contact |
Kevin Cook |
Correspondent |
MedVenture Health |
299 S Main Street, Suite 2300 |
Salt Lake City,
UT
84111
|
|
Correspondent Contact |
Jonathan Holmes |
Regulation Number | 862.1675
|
Classification Product Code |
|
Date Received | 01/31/2022 |
Decision Date | 07/14/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|