The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Jostra Quadrox D Diffusion Membrane Oxygenator With Bioline Coating, Model Be-hmod 2000, Beq-hmod 2030.
| Device ID | K071774 |
| 510k Number | K071774 |
| Device Name: | JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030 |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Contact | Katrin Schwenkglenks |
| Correspondent | Katrin Schwenkglenks MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-29 |
| Decision Date | 2008-01-23 |
| Summary: | summary |