DEFI 2— 510(k) K851931

Name: FDA 510(k) clearance K851931
Creator: U.S. Food and Drug Administration
Published: 1985-08-05

Substantially Equivalent

S & W Medico Teknik

FDA 510(k) clearance K851931 for DEFI 2, Substantially Equivalent on 1985-08-05. Applicant: S & W Medico Teknik. Device class: 2.

Clearance details

Applicant: S & W Medico Teknik
Product code: Code LDD
Device class: Class 2
Regulation: 21 CFR 870.5300
Advisory panel: Cardiovascular
Date received: 1985-05-02
Decision date: 1985-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.