ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000— 510(k) K000013

Substantially Equivalent

Acist Medical Systems

FDA 510(k) clearance K000013 for ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000, Substantially Equivalent on 2000-03-28. Applicant: Acist Medical Systems.

Clearance details

Applicant: Acist Medical Systems
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2000-01-03
Decision date: 2000-03-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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.