MUCAID— 510(k) K910909

Name: FDA 510(k) clearance K910909
Creator: U.S. Food and Drug Administration
Published: 1991-05-20

Substantially Equivalent

Vygon Corp.

FDA 510(k) clearance K910909 for MUCAID, Substantially Equivalent on 1991-05-20. Applicant: Vygon Corp.. Device class: 1.

Clearance details

Applicant: Vygon Corp.
Product code: Code BSY
Device class: Class 1
Regulation: 21 CFR 868.6810
Advisory panel: Anesthesiology
Date received: 1991-03-05
Decision date: 1991-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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K981910 — SUCTION CATHETER1998-08-24
K972258 — HI-CARE CLOSED SUCTION SYSTEM1997-12-29

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K073493 — HEPATOSTAT SET2008-05-06
K070705 — MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.0392007-11-30
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Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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.