ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System— 510(k) K203004

Substantially Equivalent

Acist Medical Systems, Inc.

FDA 510(k) clearance K203004 for ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System, Substantially Equivalent on 2020-12-17. Applicant: Acist Medical Systems, Inc..

Clearance details

Applicant: Acist Medical Systems, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2020-10-01
Decision date: 2020-12-17
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.