The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Quadrox-i Adult Microporous Membrane Oxygenator With Bioline Coating, Model Behmo70000,beq-hmo70000.
| Device ID | K090511 |
| 510k Number | K090511 |
| Device Name: | QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000 |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Contact | Frank Moehrke |
| Correspondent | Frank Moehrke MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-02-26 |
| Decision Date | 2009-06-12 |
| Summary: | summary |