ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter— 510(k) K193183

Substantially Equivalent

Acist Medical Systems, Inc.

FDA 510(k) clearance K193183 for ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter, Substantially Equivalent on 2020-03-20. Applicant: Acist Medical Systems, Inc..

Clearance details

Applicant: Acist Medical Systems, Inc.
Product code: Code OBJ
Advisory panel: Cardiovascular
Date received: 2019-11-18
Decision date: 2020-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Eden Prairie, MN, US

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Adverse events under product code OBJ

product code OBJ

Death: 38
Injury: 634
Malfunction: 3,453
Total: 4,125

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.