The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Quadrox-i Adult/small Adult Oxygenators;quadrox-id Adult Oxygenators.
| Device ID | K150267 |
| 510k Number | K150267 |
| Device Name: | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 Rastatt, DE 76437 |
| Contact | Whitney Torning |
| Correspondent | Whitney Torning MAQUET Cardiovascular 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-04 |
| Decision Date | 2015-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04058863019192 | K150267 | 000 |
| 04037692010594 | K150267 | 000 |
| 04037692010570 | K150267 | 000 |
| 04037692009925 | K150267 | 000 |
| 04037692009932 | K150267 | 000 |
| 04037692010556 | K150267 | 000 |
| 04037692010563 | K150267 | 000 |
| 04037692010532 | K150267 | 000 |
| 04037692011379 | K150267 | 000 |
| 04058863017358 | K150267 | 000 |
| 04058863017389 | K150267 | 000 |
| 04058863019000 | K150267 | 000 |
| 04058863019024 | K150267 | 000 |
| 04058863019062 | K150267 | 000 |
| 04058863019086 | K150267 | 000 |
| 04058863019154 | K150267 | 000 |
| 04058863019178 | K150267 | 000 |
| 04037692010471 | K150267 | 000 |