ACIST INJECTOR SYSTEM, MODEL CL100 H— 510(k) K984058

Substantially Equivalent

Acist Medical Systems

FDA 510(k) clearance K984058 for ACIST INJECTOR SYSTEM, MODEL CL100 H, Substantially Equivalent on 1999-02-11. Applicant: Acist Medical Systems.

Clearance details

Applicant: Acist Medical Systems
Product code: Code IZQ
Advisory panel: Cardiovascular
Date received: 1998-11-13
Decision date: 1999-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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Adverse events under product code IZQ

product code IZQ

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.