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Edwards Introducer Sheath

FDA 510(k)

Class II (US FDA 510(k))

510(k) K031087

by Edwards Lifesciences LLC

Identifiers

510(k) Number
K031087 FDA 510(k)
FDA Product Code
DYB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1340 FDA 510(k)
Regulation Number
870.1340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Edwards Introducer Sheath is a vascular access device classified as a vascular introducer sheath (Product Code: DYB). It is designed to facilitate the insertion of guidewires, catheters, and other interventional devices into blood vessels, enabling minimally invasive cardiovascular procedures. Its primary function is to provide a stable pathway for diagnostic and therapeutic interventions, reducing trauma to vessel walls during manipulation. The device is intended for use in percutaneous procedures under fluoroscopic guidance, ensuring precise placement within the vascular system.

The Edwards Introducer Sheath is supplied as a single-use, sterile device and is intended for reusable introducer systems in cardiovascular applications. It is available in sizes and configurations compatible with standard interventional techniques, including hydrophilic-coated variants for enhanced ease of insertion. The device is regulated under FDA 510(k) clearance (K031087) and is intended for use in settings such as cardiac catheterization labs and electrophysiology suites. Storage and handling must adhere to sterile medical device protocols to maintain integrity prior to use.

Frequently asked questions

What is the Edwards Introducer Sheath used for?

The Edwards Introducer Sheath is designed to create a stable pathway in blood vessels for inserting guidewires, catheters, and other interventional tools during minimally invasive cardiovascular procedures. Its primary purpose is to minimize trauma to vessel walls while enabling precise placement under fluoroscopic guidance, supporting both diagnostic and therapeutic interventions in settings like cardiac catheterization labs and electrophysiology suites.

Is the Edwards Introducer Sheath single-use or reusable?

The Edwards Introducer Sheath is intended for single-use only, even though it is compatible with reusable introducer systems. This ensures sterility and safety for each procedure, adhering to standard sterile medical device protocols. Reusing the sheath could compromise integrity and introduce infection risks, so it must be discarded after one use.

What sizes and configurations are available for the Edwards Introducer Sheath?

The Edwards Introducer Sheath is available in multiple sizes and configurations to match standard interventional techniques. Notably, some variants feature a hydrophilic coating, which reduces friction and improves ease of insertion. Exact sizing details (e.g., French gauge or diameter ranges) are not specified in the provided data, but compatibility with common cardiovascular procedures is ensured. For precise specifications, refer to the manufacturer’s technical documentation or product catalog.

How should the Edwards Introducer Sheath be stored?

The Edwards Introducer Sheath must be stored according to sterile medical device protocols to preserve its integrity before use. This typically includes keeping it in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid contamination or exposure to moisture, as this could compromise sterility. Always check expiration dates and ensure the packaging remains intact prior to procedure.

Is the Edwards Introducer Sheath regulated by the FDA?

Yes, the Edwards Introducer Sheath is regulated under the FDA 510(k) clearance process, with the specific clearance number K031087. This classification confirms it is deemed substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness in its intended use for vascular access during cardiovascular procedures. The device falls under Product Code DYB (vascular introducer sheath).

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: Edwards Lifesciences – the leading global structural heart innovation ..., PDF Edwards Expandable Introducer Sheath Set, PDF Edwards eSheath+ Introducer Set - Edwards Lifesciences, K031087 FDA 510 (k) - EDWARDS INTRODUCER SHEATH

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Edwards Lifesciences LLC
FDA Applicant
Edwards Lifesciences, LLC

Sources (1)

  • FDA 510(k) K031087 24 fields · synced Oct 1, 2026