K193183

Substantially Equivalent

ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter

Applicant: Acist Medical Systems, Inc.
Product 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

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.