DeviceClearance

K240908

Substantially Equivalent

Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)

Applicant
Spectrum Medical , Ltd.
Product code
DTR
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Gloucester, GB
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.