Device Classification Name |
console, heart-lung machine, cardiopulmonary bypass
|
510(k) Number |
K202125 |
Device Name |
Century Perfusion System |
Applicant |
Century HLM, LLC |
3110 N. Oakland, STE 101 |
Mesa,
AZ
85215
|
|
Applicant Contact |
Jeff Poland |
Correspondent |
mdi Consultants,Inc. |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Correspondent Contact |
Vaibhav Arvind Rajal |
Regulation Number | 870.4220
|
Classification Product Code |
|
Date Received | 07/31/2020 |
Decision Date | 03/07/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|