BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES— 510(k) K892641

Substantially Equivalent

Bard Cardiosurgery Div

FDA 510(k) clearance K892641 for BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES, Substantially Equivalent on 1989-11-01. Applicant: Bard Cardiosurgery Div.

Clearance details

Applicant: Bard Cardiosurgery Div
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 1989-04-12
Decision date: 1989-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, 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.