The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Quadrox-i Pediatric Microporous Membrane Oxygenator With Integrated Arterial Filter With Softline / Bioline Coating.
| Device ID | K103191 |
| 510k Number | K103191 |
| Device Name: | QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING |
| 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 |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2010-10-28 |
| Decision Date | 2011-03-08 |
| Summary: | summary |