BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600— 510(k) K864235

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K864235 for BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600, Substantially Equivalent on 1987-01-02. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 1986-10-28
Decision date: 1987-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murray Hill, NJ, 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.