Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K863476 |
Device Name |
SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO |
Applicant |
SCIMED LIFE SYSTEMS, INC. |
13000 COUNTY RD 6 |
MINNEAPOLIS,
MN
55441
|
|
Applicant Contact |
MICHAEL FRANKENBERG |
Correspondent |
SCIMED LIFE SYSTEMS, INC. |
13000 COUNTY RD 6 |
MINNEAPOLIS,
MN
55441
|
|
Correspondent Contact |
MICHAEL FRANKENBERG |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 09/09/1986 |
Decision Date | 11/25/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|