CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER— 510(k) K132474

Substantially Equivalent

Acist Medical Systems

FDA 510(k) clearance K132474 for CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER, Substantially Equivalent on 2014-01-30. Applicant: Acist Medical Systems.

Clearance details

Applicant: Acist Medical Systems
Product code: Code DXO
Advisory panel: Cardiovascular
Date received: 2013-08-07
Decision date: 2014-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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Adverse events under product code DXO

product code DXO

Death: 10
Injury: 156
Malfunction: 884
Total: 1,050

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.