The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Venous Hardshell Cardiotomy Reserviors.
| Device ID | K090534 |
| 510k Number | K090534 |
| Device Name: | VENOUS HARDSHELL CARDIOTOMY RESERVIORS |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Contact | Frank Moehrke |
| Correspondent | Frank Moehrke MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-02-27 |
| Decision Date | 2009-12-23 |
| Summary: | summary |