← Back to catalogue

TalWire

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223791

by Embrace Medical , Ltd.

Identifiers

510(k) Number
K223791 FDA 510(k)
FDA Product Code
DQX 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 TalWire is a catheter guide wire, classified under 21 CFR 870.1330 as a Class II medical device. It is designed to assist in the navigation and positioning of catheters within the cardiovascular system, facilitating procedures such as angioplasty, stent placement, or diagnostic imaging.

This device is supplied as a single-use, non-sterile product (unless terminally sterilized per packaging instructions) and is intended for use in controlled clinical or interventional settings. It complies with FDA 510(k) clearance (K223791) and is regulated under the Product Code DQX for cardiovascular applications. Storage conditions and sterility status must adhere to manufacturer guidelines as specified on the packaging.

Frequently asked questions

What is the TalWire designed to assist with during cardiovascular procedures?

The TalWire is specifically designed to help guide and position catheters within the cardiovascular system. This support is critical for procedures like angioplasty, stent placement, or diagnostic imaging, where precise catheter navigation is essential for success.

Is the TalWire intended for reuse or single-use, and how does sterility factor into its use?

The TalWire is supplied as a single-use device. While it is initially non-sterile, it can be terminally sterilized following the manufacturer’s instructions on the packaging. This ensures it meets sterility requirements for controlled clinical or interventional settings before use.

How should the TalWire be stored, and what should clinicians consider regarding its regulatory compliance?

Storage conditions for the TalWire must strictly follow the manufacturer’s guidelines outlined on the packaging to maintain its integrity and performance. Clinically, it is regulated under FDA 510(k) clearance (K223791) and falls under Product Code DQX for cardiovascular applications, ensuring it adheres to U.S. medical device regulations for interventional use.

What type of regulatory pathway did the TalWire follow to gain market authorization in the U.S.?

The TalWire received FDA clearance through a traditional 510(k) pathway, classified as substantially equivalent to a predicate device. The review was conducted by the Cardiovascular (CV) Advisory Committee, and the decision was finalized on July 14, 2023, confirming its compliance for cardiovascular applications.

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 July 14, 2023 - Food and Drug Administration, K223791 FDA 510 (k) - TalWire | Embrace Medical , Ltd., Embrace Medical , Ltd. FDA Filings - FDA.report, Embrace Medical , Ltd. FDA 510 (k) Products 2023, TalWire 17290019773020 Medical Device Identification

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Embrace Medical , Ltd.

Sources (1)

  • FDA 510(k) K223791 24 fields · synced Oct 6, 2026