Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K201642 |
Device Name |
Paragon Adult Maxi PMP Oxygenator with Tubing Pack |
Applicant |
Chalice Medical Ltd |
Manton Wood Enterprise Park |
Worksop,
GB
S80 2RS
|
|
Applicant Contact |
Stephen Horan |
Correspondent |
Chalice Medical Ltd |
Manton Wood Enterprise Park |
Worksop,
GB
S80 2RS
|
|
Correspondent Contact |
Stephen Horan |
Regulation Number | 870.4350
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/17/2020 |
Decision Date | 09/18/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|