Device Classification Name |
transducer, blood-pressure, extravascular
|
510(k) Number |
K172458 |
Device Name |
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit |
Applicant |
Smiths Medical ASD, Inc. |
6000 Nathan Lane North |
Minneapolis,
MN
55442
|
|
Applicant Contact |
Mikael Evans |
Correspondent |
Smiths Medical ASD, Inc. |
6000 Nathan Lane North |
Minneapolis,
MN
55442
|
|
Correspondent Contact |
Mikael Evans |
Regulation Number | 870.2850
|
Classification Product Code |
|
Date Received | 08/14/2017 |
Decision Date | 11/09/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|