INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,— 510(k) K092782

Name: FDA 510(k) clearance K092782
Creator: U.S. Food and Drug Administration
Published: 2009-12-07

Substantially Equivalent

Carmel Pharma Ab.

FDA 510(k) clearance K092782 for INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,, Substantially Equivalent on 2009-12-07. Applicant: Carmel Pharma Ab.. Device class: 2.

Clearance details

Applicant: Carmel Pharma Ab.
Product code: Code LHI
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2009-09-10
Decision date: 2009-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Molndal, SE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.