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Atrion Medical QL Fluid Dispensing Syringe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K020333

by Atrion Medical Products, Inc.

Identifiers

510(k) Number
K020333 FDA 510(k)
FDA Product Code
DXT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1650 FDA 510(k)
Regulation Number
870.1650 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Atrion Medical QL Fluid Dispensing Syringe is classified as an Injector and Syringe, Angiographic, designed for precise fluid delivery in medical procedures. It is engineered to provide controlled dispensing of liquids, ensuring accuracy and reliability in clinical applications such as angiography and related interventions.

This device is intended for single-use and is supplied sterile, adhering to regulatory standards for medical injectors. It is categorized under FDA 510K clearance (K020333) and falls under Device Class II, with a regulatory number of 870.1650. The syringe is manufactured by Atrion Medical Products, Inc., and is intended for use in controlled clinical settings where precise fluid management is required.

Frequently asked questions

What types of medical procedures is the Atrion Medical QL Fluid Dispensing Syringe designed for?

The Atrion Medical QL Fluid Dispensing Syringe is specifically engineered for precise fluid delivery in controlled clinical settings, particularly in procedures like angiography and related cardiovascular interventions. Its design ensures accuracy and reliability for applications requiring meticulous control over liquid dispensing.

Is the Atrion Medical QL Fluid Dispensing Syringe intended for single-use or repeated use?

The device is explicitly designed for single-use only, adhering to regulatory standards for sterile medical injectors. This ensures patient safety and prevents cross-contamination between procedures.

How is the Atrion Medical QL Fluid Dispensing Syringe supplied, and what does that mean for handling?

The syringe is supplied sterile from the manufacturer, meaning it is pre-sterilized and packaged to maintain sterility until use. This eliminates the need for additional sterilization by the clinician, simplifying preparation and reducing risk of contamination.

What regulatory pathway was followed for FDA clearance of this device?

The Atrion Medical QL Fluid Dispensing Syringe received FDA 510(k) clearance under the traditional review pathway, classified as Substantially Equivalent to a predicate device. The submission was reviewed by the Cardiovascular (CV) Advisory Committee, and the device falls under FDA Device Class II with the regulatory number 870.1650.

Are there different sizes or models available for the Atrion Medical QL Fluid Dispensing Syringe?

The provided data does not specify exact sizes or model variations (e.g., barrel capacity, plunger types, or connector styles) for the QL Fluid Dispensing Syringe. However, the OpenFDA registration numbers suggest multiple FEI (Facility Establishment Identifier) listings, which may indicate variations in production or distribution but do not confirm distinct clinical sizes/models. For precise sizing details, refer to the manufacturer’s technical documentation or catalog.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Atrion Medical Devices, Atrion QL® Inflation Devices - Nordson MEDICAL, PDF Atrion Medical Products QL® Inflation Devices Brochure (Web Version ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atrion Medical Products, Inc.

Sources (1)

  • FDA 510(k) K020333 24 fields · synced Oct 6, 2026