ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH— 510(k) K993774

Substantially Equivalent

Acist Medical Systems

FDA 510(k) clearance K993774 for ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH, Substantially Equivalent on 1999-12-07. Applicant: Acist Medical Systems.

Clearance details

Applicant: Acist Medical Systems
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1999-11-08
Decision date: 1999-12-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Eden Prairie, MN, US

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.