VARIOUS CARDIOVASCULAR SURGICAL DEVICE— 510(k) K831769

Substantially Equivalent

Research Industries Corp.

FDA 510(k) clearance K831769 for VARIOUS CARDIOVASCULAR SURGICAL DEVICE, Substantially Equivalent on 1983-08-12. Applicant: Research Industries Corp..

Clearance details

Applicant: Research Industries Corp.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 1983-06-01
Decision date: 1983-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.