CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR— 510(k) K970463

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K970463 for CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR, Substantially Equivalent on 1997-05-06. Applicant: Terumo Medical Corp..

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 1997-02-06
Decision date: 1997-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

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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.