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Preface Guiding Sheath, Models 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M

FDA 510(k)

Class II (US FDA 510(k))

510(k) K001139

by Biosense Webster Inc

Identifiers

510(k) Number
K001139 FDA 510(k)
FDA Product Code
DYB FDA 510(k)
Models / Variants
2-603m FDA 510(k)
2-703m FDA 510(k)
2-803m FDA 510(k)
2-903m FDA 510(k)
2-1003m FDA 510(k)
2-1103m 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 Preface Guiding Sheath is a catheter introducer designed to facilitate the insertion of catheters into the vascular system. It provides a protective conduit for guiding diagnostic or therapeutic catheters through the skin into veins or arteries, ensuring safe and precise placement during cardiovascular procedures.

These sheaths are supplied sterile and intended for single-use. They are classified under product code DYB and were cleared through the FDA 510(k) pathway as substantially equivalent to a predicate device. Models 2-603M through 2-1103M are available, with varying specifications tailored for different procedural requirements, and are regulated as Class 2 medical devices.

Frequently asked questions

What types of procedures is the Preface Guiding Sheath intended to support during catheter insertion?

The Preface Guiding Sheath is designed to facilitate the insertion of diagnostic or therapeutic catheters into the vascular system, providing a protective conduit for safe and precise placement. It is commonly used in cardiovascular procedures where catheters need to be guided through veins or arteries, ensuring stability and reducing the risk of complications during insertion.

Are the Preface Guiding Sheath models interchangeable, or do they have specific procedural applications?

The Preface Guiding Sheath comes in multiple models (2-603M through 2-1103M), each tailored to different procedural requirements. While they share the same core function of guiding catheters, the varying specifications likely accommodate differences in catheter size, patient anatomy, or procedural needs. Always verify the model’s compatibility with your intended catheter and procedure.

How should the Preface Guiding Sheath be stored before use, and what are the sterility guarantees?

The Preface Guiding Sheath is supplied sterile and intended for single-use only. Proper storage should follow manufacturer guidelines to maintain sterility, typically involving sealed packaging and protection from contamination. Since it is sterile upon receipt, it should not be reused or resterilized.

What regulatory pathway was used for FDA clearance of the Preface Guiding Sheath, and what does that mean for its classification?

The Preface Guiding Sheath was cleared through the FDA’s 510(k) pathway, specifically under a Special clearance type, and is classified as a Class 2 medical device. This means it was determined to be substantially equivalent to a predicate device (already on the market) and requires compliance with additional controls beyond general controls, such as performance standards or labeling requirements, but does not carry the higher scrutiny of a Class 3 device.

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: Preface Guiding Sheath, Models 2-603m, 2-703m, 2-803m, 2-903m, 2-1003m ..., PREFACE Definition & Meaning - Merriam-Webster, Preface Guiding Sheath, Models 2-603m, 2-703m, 2-803m, 2-903m, 2-1003m ..., preface guiding sheath models 2-603m 2-703m 2-803m 2-903m 2-1003m 2-1103m

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biosense Webster Inc
FDA Applicant
Biosense Webster, Inc.

Sources (1)

  • FDA 510(k) K001139 24 fields · synced Sep 19, 2026