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FMD Peripheral Guide Wire F-14 Flex 6 +4 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K260544

by FMD Co., Ltd.

Identifiers

510(k) Number
K260544 FDA 510(k)
FDA Product Code
DQX FDA 510(k)
Models / Variants
FMD Peripheral Guide Wire F-14 Flex 6 FDA 510(k)
FMD Peripheral Guide Wire F-14 Tapered 40 FDA 510(k)
FMD Peripheral Guide Wire F-18 Flex SP FDA 510(k)
FMD Peripheral Guide Wire F-18 DP 25 FDA 510(k)
FMD Peripheral Guide Wire F-18 Tapered 40 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1330 FDA 510(k)
Regulation Number
870.1330 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The FMD Peripheral Guide Wire series consists of flexible, tapered, and diagnostic peripheral guidewires designed for use in peripheral intravascular procedures. These devices are classified as guidewires under the product code DQX and are intended to assist in the placement and exchange of diagnostic and therapeutic devices within peripheral blood vessels. Each model varies in diameter and tip configuration to accommodate specific clinical needs, including enhanced maneuverability and stability during procedures.

These guidewires are supplied sterile and intended for single-use. They are regulated under FDA 510(k) clearance (K260544) with a special review designation, classified under the Cardiovascular advisory committee. The models include distinct sizes and tip designs—such as Flex 6, Tapered 40, Flex SP, DP 25, and Tapered 40—each tailored for specific procedural requirements. Non-clinical bench testing was conducted to evaluate performance, ensuring compliance with regulatory standards before market distribution.

Frequently asked questions

What are the FMD Peripheral Guide Wire series designed for?

The FMD Peripheral Guide Wire series is specifically designed for peripheral intravascular procedures. These guidewires assist in the placement and exchange of diagnostic and therapeutic devices within peripheral blood vessels. Each model, such as the F-14 Flex 6, F-18 Flex SP, or F-18 DP 25, features distinct diameters and tip configurations to improve maneuverability and stability during procedures, ensuring optimal performance for various clinical needs.

Are the FMD Peripheral Guide Wire models reusable or single-use?

The FMD Peripheral Guide Wire models are intended for single-use only. This design choice ensures sterility and reduces the risk of cross-contamination between patients, aligning with best practices for medical device safety and regulatory compliance.

How are the FMD Peripheral Guide Wire models supplied?

All FMD Peripheral Guide Wire models are supplied sterile, ready for immediate clinical use. Sterility is maintained through manufacturing processes that comply with regulatory standards, ensuring reliability and safety for procedures.

What distinguishes the different models in the FMD Peripheral Guide Wire series?

The models in the FMD Peripheral Guide Wire series differ primarily by diameter and tip configuration. For example, the F-18 Flex SP is designed for enhanced flexibility, while the F-18 DP 25 offers a diagnostic tip for specific procedural requirements. These variations allow clinicians to select the appropriate wire based on the complexity of the vessel and the intended use, such as catheter placement or exchange.

What regulatory pathway does the FMD Peripheral Guide Wire series follow?

The FMD Peripheral Guide Wire series follows the FDA 510(k) clearance pathway, specifically with clearance number K260544. This process includes a special review designation and classification under the Cardiovascular advisory committee, ensuring that the devices meet stringent regulatory standards before market distribution. The classification under product code DQX confirms their intended use for guidewire applications in peripheral intravascular procedures.

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: F-14™* and F-18™* peripheral guidewires - Medtronic, FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 ..., K260544 FDA 510 (k) - FMD Peripheral Guide Wire F-14 Flex 6

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
FMD Co., Ltd.

Sources (1)

  • FDA 510(k) K260544 24 fields · synced Oct 1, 2026