DeviceClearance

K984058

Substantially Equivalent

ACIST INJECTOR SYSTEM, MODEL CL100 H

Applicant
Acist Medical Systems
Product code
IZQ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Eden Prairie, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code IZQ

product code IZQ
Death
7
Total
7

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.