DeviceClearance

K790444

Substantially Equivalent

ELECATH MULTI-PURPOSE ARTERIAL SURGER

Applicant
Electro-Catheter Corp.
Product code
GBA
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GBA

product code GBA
Death
2
Total
2

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.