The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Quadrox-ir Adult And Small Adult.
| Device ID | K133265 |
| 510k Number | K133265 |
| Device Name: | QUADROX-IR ADULT AND SMALL ADULT |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| 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 | KFM |
| Subsequent Product Code | DTM |
| Subsequent Product Code | DTR |
| Subsequent Product Code | DTZ |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-10-23 |
| Decision Date | 2013-11-12 |
| Summary: | summary |