Device Classification Name |
apparatus, autotransfusion
|
510(k) Number |
K180831 |
Device Name |
CATSmart |
Applicant |
Fresenius Kabi AG |
Else-Kroner-Strasse 1 |
Bad Homburg,
DE
61352
|
|
Applicant Contact |
Barry G. Hicks |
Correspondent |
Fresenius Kabi USA |
Three Corporate Drive |
Lake Zurich,
IL
60047
|
|
Correspondent Contact |
Barry G. Hicks |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 03/30/2018 |
Decision Date | 12/10/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|