| Device Classification Name |
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
|
|---|
| 510(k) Number |
K121209 |
|---|
| Device Name |
TERUMO PALL AL20X ARTERIAL FILTER |
|---|
| Applicant |
| Terumo Cardiovascular Systems Corporation |
| 125 Blue Ball Rd. |
|
Elkton,
MD
21921
|
|
| Applicant Contact |
SUZANNE GRENIER |
| Correspondent |
| Terumo Cardiovascular Systems Corporation |
| 125 Blue Ball Rd. |
|
Elkton,
MD
21921
|
|
| Correspondent Contact |
SUZANNE GRENIER |
| Regulation Number | 870.4260 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 04/20/2012 |
|---|
| Decision Date | 05/08/2012 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Cardiovascular
|
|---|
| 510k Review Panel |
Cardiovascular
|
|---|
| Summary |
Summary
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|