IV START KIT— 510(k) K924538

Name: FDA 510(k) clearance K924538
Creator: U.S. Food and Drug Administration
Published: 1993-07-02

Unknown

Cml, Inc.

FDA 510(k) clearance K924538 for IV START KIT, Unknown on 1993-07-02. Applicant: Cml, Inc.. Device class: 2.

Clearance details

Applicant: Cml, Inc.
Product code: Code LRS
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 1992-09-08
Decision date: 1993-07-02
Decision: Unknown
Clearance type: Traditional
Location: Waterford, WI, US

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Adverse events under product code LRS

product code LRS

Other: 2
Total: 2

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.