The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Quadrox-id Pediatric Diffusion Membrane Oxygenator With Bioline Coating, Models Be-hmod 30000-usa, Beq-hmod 30000-usa.
| Device ID | K100278 |
| 510k Number | K100278 |
| Device Name: | QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA |
| 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 | Yes |
| Date Received | 2010-02-01 |
| Decision Date | 2010-04-30 |
| Summary: | summary |