COMPACT 2000— 510(k) K851892

Name: FDA 510(k) clearance K851892
Creator: U.S. Food and Drug Administration
Published: 1985-06-14

Substantially Equivalent

Atrium Medical Corp.

FDA 510(k) clearance K851892 for COMPACT 2000, Substantially Equivalent on 1985-06-14. Applicant: Atrium Medical Corp.. Device class: 2.

Clearance details

Applicant: Atrium Medical Corp.
Product code: Code KDQ
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1985-04-30
Decision date: 1985-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amherst, NH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KDQ

product code KDQ

Death: 8
Malfunction: 637
Total: 645

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.