CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)— 510(k) K080774

Substantially Equivalent

Terumo Cardiovascular Systems Corp.

FDA 510(k) clearance K080774 for CAPIOX SP PUMP (WITH OR WITHOUT X-COATING), Substantially Equivalent on 2008-04-17. Applicant: Terumo Cardiovascular Systems Corp..

Clearance details

Applicant: Terumo Cardiovascular Systems Corp.
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 2008-03-19
Decision date: 2008-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KFM

product code KFM

Death: 109
Injury: 241
Malfunction: 1,779
Total: 2,129

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.