The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Quadrox-i Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating And W/ Integrated Arterial Filter W/ Bioline C.
| Device ID | K093522 |
| 510k Number | K093522 |
| Device Name: | QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C |
| 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 |
| Subsequent Product Code | DTM |
| Subsequent Product Code | DTR |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-11-13 |
| Decision Date | 2009-12-07 |
| Summary: | summary |