DeviceClearance

K001063

Substantially Equivalent

SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7

Applicant
Baxter Healthcare Corp
Product code
DYG
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DYG

product code DYG
Death
18
Malfunction
1,051
Other
1
Total
1,070

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.