The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod 2030.
| Device ID | K061628 |
| 510k Number | K061628 |
| Device Name: | JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030 |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | MAQUET CARDIOPULMONARY AG 414 MARYJOE WAY Warrington, PA 18976 |
| Contact | James Collie |
| Correspondent | James Collie MAQUET CARDIOPULMONARY AG 414 MARYJOE WAY Warrington, PA 18976 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-12 |
| Decision Date | 2006-08-22 |
| Summary: | summary |