DeviceClearance

K001804

Substantially Equivalent

NUMED Z-5 ATRIOSEPTOSTOMY CATHETER

Applicant
NuMED, Inc.
Product code
DXF
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Hopkinton, NY, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DXF

product code DXF
Death
78
Injury
1,126
Malfunction
507
Other
1
Total
1,712

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.