The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Mecc Set With Bioline Coating.
| Device ID | K083794 |
| 510k Number | K083794 |
| Device Name: | MECC SET WITH BIOLINE COATING |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Contact | Katrin Schwenkglenks |
| Correspondent | Katrin Schwenkglenks MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-12-22 |
| Decision Date | 2009-04-21 |
| Summary: | summary |