The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Plegiox Cardioplegia Heat Exchanger, With Safeline Coating, Model(s) Chx30, Bsq-chx 30.
| Device ID | K072583 |
| 510k Number | K072583 |
| Device Name: | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30 |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| 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 | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-13 |
| Decision Date | 2008-04-04 |
| Summary: | summary |