DeviceClearance

K090555

Substantially Equivalent

PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30

Applicant
Maquet Cardiopulmonary, AG
Product code
DTR
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Hirrlingen, DE
Download summary PDF View on FDA.gov ↗

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.