The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Quadrox-i Microporporous Membrane Oxgenator Series And Qudrox-id Diffusion Membrane Oxygenators Series.
| Device ID | K112360 |
| 510k Number | K112360 |
| Device Name: | QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES |
| 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 |
| Subsequent Product Code | DTM |
| Subsequent Product Code | DTR |
| Subsequent Product Code | KFM |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-17 |
| Decision Date | 2011-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04037691229591 | K112360 | 000 |
| 04037691180038 | K112360 | 000 |
| 04058863080383 | K112360 | 000 |
| 04058863078861 | K112360 | 000 |
| 04058863076355 | K112360 | 000 |
| 04037691773513 | K112360 | 000 |
| 04037691741543 | K112360 | 000 |
| 04037691741130 | K112360 | 000 |