ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM— 510(k) K041158

Name: FDA 510(k) clearance K041158
Creator: U.S. Food and Drug Administration
Published: 2004-06-16

Substantially Equivalent

Atrion Medical Products, Inc.

FDA 510(k) clearance K041158 for ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM, Substantially Equivalent on 2004-06-16. Applicant: Atrion Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Atrion Medical Products, Inc.
Product code: Code CAZ
Device class: Class 2
Regulation: 21 CFR 868.5140
Advisory panel: Anesthesiology
Date received: 2004-05-03
Decision date: 2004-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arab, AL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

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.