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QL Locking Syringe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K060643

by Atrion Medical Products, Inc.

Identifiers

510(k) Number
K060643 FDA 510(k)
FDA Product Code
MAV 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 QL Locking Syringe is a syringe, balloon inflation device designed for controlled fluid delivery and secure locking of the plunger. Its one-piece plastic construction and integrated lock lever mechanism ensure precise control during inflation procedures, reducing the risk of accidental discharge or leakage.

This device is supplied as a disposable, single-use item and is intended for use in cardiovascular applications. It is classified as a Class II medical device under FDA regulation 870.1650 and holds an FDA 510K clearance (K060643) as substantially equivalent. Multiple reference codes (e.g., 1721676, 1000138054) identify variations in size and configuration, all of which adhere to standard sterility and safety protocols for procedural use.

Frequently asked questions

What types of cardiovascular procedures is the QL Locking Syringe designed to assist with, and why is the secure locking feature important?

The QL Locking Syringe is specifically designed for controlled fluid delivery during cardiovascular procedures, such as balloon inflation. The secure locking mechanism of the plunger is critical because it prevents accidental discharge or leakage of fluid, ensuring precise and safe inflation of balloons—such as those used in angioplasty or stent deployment—where stability and accuracy are essential.

Is the QL Locking Syringe reusable, or is it intended for single-use only? How does this affect its sterility?

The QL Locking Syringe is explicitly supplied as a disposable, single-use device. This design choice ensures sterility is maintained throughout its intended use, as reuse could compromise the integrity of the locking mechanism and introduce contamination risks, which are critical in sterile cardiovascular procedures.

What sizes or configurations of the QL Locking Syringe are available, and how do I identify the correct one for my procedure?

The QL Locking Syringe comes in multiple sizes and configurations, each identified by unique FEI numbers (e.g., 1721676, 1000138054, etc.). These variations account for different procedural needs, such as varying balloon inflation volumes. Referencing the specific FEI number or consulting the manufacturer’s documentation ensures you select the correct size for your application.

How should the QL Locking Syringe be stored to maintain its functionality and sterility before use?

Since the QL Locking Syringe is a sterile, single-use device, it should be stored in its original packaging until ready for use. The packaging is designed to protect against contamination and damage. Avoid exposure to extreme temperatures, moisture, or direct sunlight, as these conditions could compromise the device’s integrity or sterility.

What regulatory pathway was followed for the QL Locking Syringe’s approval, and how does this affect its use in clinical settings?

The QL Locking Syringe received FDA 510(k) clearance (K060643) under the Traditional 510(k) pathway, determined to be *substantially equivalent* to a legally marketed predicate device. This means it meets FDA safety and performance standards for Class II medical devices (regulated under 21 CFR 870.1650) and is suitable for use in cardiovascular procedures as intended by the manufacturer.

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: PDF Atrion Medical Products QL® Inflation Devices Brochure (Web Version ..., PDF QL Locking Syringe, PDF Atrion Medical Products QL® Inflation Devices Brochure (Web Version ..., Atrion Medical Devices

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) K060643 24 fields · synced Oct 6, 2026