Maquet Cardiopulmonary, AG · Class II · Cleared Dec 23, 2009
| K-number | K090555 |
| Device name | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 |
| Applicant | Maquet Cardiopulmonary, AG |
| Product code | DTR |
| Device class | Class II |
| Decision date | Dec 23, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 870.4240 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov