Device Classification Name |
dual lumen ecmo cannula
|
510(k) Number |
K203409 |
Device Name |
MC3 Crescent Jugular Dual Lumen Catheter |
Applicant |
MC3, Inc. |
2555 Bishop Circle West |
Dexter,
MI
48130
|
|
Applicant Contact |
Martha Rumford |
Correspondent |
MC3, Inc. |
2555 Bishop Circle West |
Dexter,
MI
48130
|
|
Correspondent Contact |
Martha Rumford |
Regulation Number | 870.4100
|
Classification Product Code |
|
Date Received | 11/19/2020 |
Decision Date | 05/03/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|