PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30— 510(k) K090555
Substantially EquivalentMaquet Cardiopulmonary, AG
FDA 510(k) clearance K090555 for PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30, Substantially Equivalent on 2009-12-23. Applicant: Maquet Cardiopulmonary, AG.
Clearance details
- Applicant
- Maquet Cardiopulmonary, AG
- Product code
- Code DTR
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hirrlingen, DE
Adverse events under product code DTR
product code DTR- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.