The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Cardiohelp System.
| Device ID | K133598 |
| 510k Number | K133598 |
| Device Name: | CARDIOHELP SYSTEM |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | MAQUET CARDIOPULMONARY AG 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Contact | Helder A Sousa |
| Correspondent | Helder A Sousa MAQUET CARDIOPULMONARY AG 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-22 |
| Decision Date | 2014-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04058863112176 | K133598 | 000 |
| 04058863074863 | K133598 | 000 |
| 04037691734941 | K133598 | 000 |
| 04037691456577 | K133598 | 000 |
| 04037691816449 | K133598 | 000 |
| 04037691643526 | K133598 | 000 |