The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Cardiohelp System.
| Device ID | K102726 |
| 510k Number | K102726 |
| Device Name: | CARDIOHELP SYSTEM |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Contact | Roland Jehle |
| Correspondent | Roland Jehle MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-21 |
| Decision Date | 2011-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04058863084336 | K102726 | 000 |
| 04037691687308 | K102726 | 000 |
| 04037691682549 | K102726 | 000 |
| 04037691320786 | K102726 | 000 |
| 04037691260730 | K102726 | 000 |