CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER— 510(k) K071494

Substantially Equivalent

Terumo Corp.

FDA 510(k) clearance K071494 for CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER, Substantially Equivalent on 2007-07-16. Applicant: Terumo Corp..

Clearance details

Applicant: Terumo Corp.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2007-05-30
Decision date: 2007-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTZ

product code DTZ

Death: 182
Injury: 422
Malfunction: 3,636
Total: 4,240

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.