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Lawmax Dilator

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K123842

by Lifetech Scientific (Shenzhen) Co., Ltd.

Identifiers

510(k) Number
K123842 FDA 510(k)
FDA Product Code
DRE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1310 FDA 510(k)
Regulation Number
870.1310 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Lawmax Dilator is a Dilator, Vessel, For Percutaneous Catheterization, designed to facilitate the dilation of peripheral vasculature. It is intended for use in interventional cardiology procedures to enlarge narrowed or obstructed blood vessels, improving blood flow during catheterization.

This device is supplied as a single-use, non-sterile instrument and is classified under FDA regulation 870.1310 as a Class II medical device. It has received FDA 510(k) clearance (K123842) and MDD authorization, ensuring compliance with regulatory standards. Multiple reference codes (e.g., LT-DIL-22F) denote specific sizes or variants, and it is intended for use in controlled clinical settings where sterility and precision are critical.

Frequently asked questions

What is the primary use of the Lawmax Dilator in clinical settings?

The Lawmax Dilator is specifically designed for use in interventional cardiology procedures to dilate narrowed or obstructed peripheral blood vessels. Its purpose is to improve blood flow during percutaneous catheterization by enlarging the vessel lumen, ensuring smoother passage and access for catheters.

Is the Lawmax Dilator intended for single-use or reusable applications?

The Lawmax Dilator is explicitly supplied as a single-use device. This design ensures patient safety and sterility, as reuse could compromise integrity and introduce contamination risks in clinical settings where precision is critical.

How do I identify the correct size or variant of the Lawmax Dilator for my procedure?

The Lawmax Dilator comes in multiple sizes or variants, each denoted by specific reference codes (e.g., LT-DIL-22F). These codes correspond to different dilator diameters or configurations, allowing clinicians to select the appropriate size based on the patient’s vessel anatomy and procedural requirements.

Why isn’t the Lawmax Dilator sterile when supplied?

The Lawmax Dilator is intentionally supplied in a non-sterile state to accommodate controlled clinical environments where terminal sterilization (e.g., ethylene oxide or gamma irradiation) can be performed just before use. This approach balances regulatory compliance with procedural flexibility, ensuring sterility is achieved only when needed for the specific procedure.

What regulatory pathways does the Lawmax Dilator follow, and how does that affect its use?

The Lawmax Dilator has received FDA 510(k) clearance (K123842) and MDD authorization, confirming compliance with U.S. and European regulatory standards. Its classification as a Class II device under FDA regulation 870.1310 and its submission to the Cardiovascular (CV) Advisory Committee indicate it undergoes rigorous review for safety and effectiveness in interventional cardiology. Clinicians can rely on these approvals to ensure the device meets established performance criteria for vascular dilation.

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: LAWMAX DILATOR 510 (k) K123842 - FDA.report, LAWMAX DILATOR (K123842) — FDA 510(k) | Innolitics, Lifetech Scientific (Shenzhen) Co., Ltd. LT-DIL-22F LawMax Dilator, LAWMAX DILATOR 510 (k) K123842 - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lifetech Scientific (Shenzhen) Co., Ltd.

Sources (2)

  • FDA 510(k) K123842 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026