Device Classification Name |
oxygenator, long term support greater than 6 hours
|
510(k) Number |
K191935 |
Device Name |
Nautilus Smart ECMO Module |
Applicant |
MC3 Incorporated |
2555 Bishop Circle W |
Dexter,
MI
48130
|
|
Applicant Contact |
Adam Viitala |
Correspondent |
MC3 Incorporated |
2555 Bishop Circle W |
Dexter,
MI
48130
|
|
Correspondent Contact |
Martha Rumford |
Regulation Number | 870.4100
|
Classification Product Code |
|
Date Received | 07/19/2019 |
Decision Date | 04/09/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|