The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Quadrox-id Adult Diffusion Membrane Oxygenator With Softline Coating, Model: Be-hmod 70000-usa, Beq-hmod 70000-usa, Hmod.
| Device ID | K101153 |
| 510k Number | K101153 |
| Device Name: | QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD |
| 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 | 2010-04-23 |
| Decision Date | 2010-12-08 |
| Summary: | summary |