FLUTTER(R)— 510(k) K940986

Name: FDA 510(k) clearance K940986
Creator: U.S. Food and Drug Administration
Published: 1994-05-24

Substantially Equivalent

Varioraw SA

FDA 510(k) clearance K940986 for FLUTTER(R), Substantially Equivalent on 1994-05-24. Applicant: Varioraw SA. Device class: 2.

Clearance details

Applicant: Varioraw SA
Product code: Code BYI
Device class: Class 2
Regulation: 21 CFR 868.5665
Advisory panel: Anesthesiology
Date received: 1994-03-01
Decision date: 1994-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brunswick, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

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.