ATRION MEDICAL QL FLUID DISPENSING SYRINGE— 510(k) K020333

Substantially Equivalent

Atrion Medical Products, Inc.

FDA 510(k) clearance K020333 for ATRION MEDICAL QL FLUID DISPENSING SYRINGE, Substantially Equivalent on 2002-04-25. Applicant: Atrion Medical Products, Inc..

Clearance details

Applicant: Atrion Medical Products, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2002-01-31
Decision date: 2002-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arab, AL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.