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

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..

Clearance details

Applicant: Atrion Medical Products, Inc.
Product code: Code CAZ
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 ↗

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.