CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER— 510(k) K920846

Name: FDA 510(k) clearance K920846
Creator: U.S. Food and Drug Administration
Published: 1992-09-01

Unknown

Trinity Laboratories, Inc.

FDA 510(k) clearance K920846 for CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER, Unknown on 1992-09-01. Applicant: Trinity Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Trinity Laboratories, Inc.
Product code: Code FXX
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1992-02-25
Decision date: 1992-09-01
Decision: Unknown
Clearance type: Traditional
Location: Salisbury, MD, US

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Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.