CARDIMAX FX-406U— 510(k) K854505

Substantially Equivalent

Brentwood Instruments, Inc.

FDA 510(k) clearance K854505 for CARDIMAX FX-406U, Substantially Equivalent on 1986-02-04. Applicant: Brentwood Instruments, Inc..

Clearance details

Applicant: Brentwood Instruments, Inc.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 1985-11-12
Decision date: 1986-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

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Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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.