ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit— 510(k) K191060

Substantially Equivalent

Acist Medical Systems, Inc.

FDA 510(k) clearance K191060 for ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit, Substantially Equivalent on 2019-07-18. Applicant: Acist Medical Systems, Inc..

Clearance details

Applicant: Acist Medical Systems, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2019-04-22
Decision date: 2019-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
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.