CAPIOX SP PUMP HEAD— 510(k) K943861

Substantially Equivalent

Terumo Corp.

FDA 510(k) clearance K943861 for CAPIOX SP PUMP HEAD, Substantially Equivalent on 1995-08-15. Applicant: Terumo Corp..

Clearance details

Applicant: Terumo Corp.
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 1994-08-08
Decision date: 1995-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

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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.