The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Quadrox-i, Quadrox-id, Quadrox-ir Oxygenators.
| Device ID | K132829 |
| 510k Number | K132829 |
| Device Name: | QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | MAQUET CARDIOPULMONARY AG 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Contact | Whitney Torning |
| Correspondent | Whitney Torning MAQUET CARDIOPULMONARY AG 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Product Code | DTZ |
| Subsequent Product Code | DTM |
| Subsequent Product Code | DTR |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-09-09 |
| Decision Date | 2013-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04037691843353 | K132829 | 000 |
| 04037691870304 | K132829 | 000 |
| 04037691452982 | K132829 | 000 |
| 04037691670171 | K132829 | 000 |
| 04037691725079 | K132829 | 000 |
| 04037691727868 | K132829 | 000 |
| 04037691739335 | K132829 | 000 |
| 04037691741161 | K132829 | 000 |
| 04037691770987 | K132829 | 000 |
| 04037691780481 | K132829 | 000 |
| 04037691782089 | K132829 | 000 |
| 04058863299983 | K132829 | 000 |