| Device Classification Name |
Oxygenator, Cardiopulmonary Bypass
|
|---|
| 510(k) Number |
K071774 |
|---|
| Device Name |
JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030 |
|---|
| Applicant |
| Maquet Cardiopulmonary, AG |
| Hechinger Strasse 38 |
|
Hirrlingen,
DE
72145
|
|
| Applicant Contact |
KATRIN SCHWENKGLENKS |
| Correspondent |
| Maquet Cardiopulmonary, AG |
| Hechinger Strasse 38 |
|
Hirrlingen,
DE
72145
|
|
| Correspondent Contact |
KATRIN SCHWENKGLENKS |
| Regulation Number | 870.4350 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 06/29/2007 |
|---|
| Decision Date | 01/23/2008 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Cardiovascular
|
|---|
| 510k Review Panel |
Cardiovascular
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|
| Recalls |
CDRH Recalls
|
|---|