OPUS MODEL 4021, VVI, 5MM UNIPOLAR— 510(k) K900461

Substantially Equivalent

Ela Medical, Inc.

FDA 510(k) clearance K900461 for OPUS MODEL 4021, VVI, 5MM UNIPOLAR, Substantially Equivalent on 1990-03-14. Applicant: Ela Medical, Inc..

Clearance details

Applicant: Ela Medical, Inc.
Product code: Code DXY
Advisory panel: Cardiovascular
Date received: 1990-01-31
Decision date: 1990-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

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Adverse events under product code DXY

product code DXY

Death: 240
Injury: 2,328
Malfunction: 2,096
Total: 4,664

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.