ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System— 510(k) K173063

Substantially Equivalent

Acist Medical Systems, Inc.

FDA 510(k) clearance K173063 for ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System, Substantially Equivalent on 2017-10-23. Applicant: Acist Medical Systems, Inc..

Clearance details

Applicant: Acist Medical Systems, Inc.
Product code: Code OBJ
Advisory panel: Cardiovascular
Date received: 2017-09-29
Decision date: 2017-10-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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.