SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS— 510(k) K951247

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K951247 for SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS, Substantially Equivalent on 1995-11-02. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 1995-03-20
Decision date: 1995-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.