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Guidewire Introducer Set

by B. Braun of America, Inc.

510(k) K915421

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK915421 Date27 Feb 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Guidewire Introducer Set is a catheter introducer (Product Code: DYB), designed to facilitate the insertion of guidewires and catheters into the vascular system. It serves as a sheath to minimize trauma during percutaneous access, enabling precise navigation of guidewires and subsequent catheter placement in veins or arteries.

This device is supplied as a sterile, single-use medical instrument, intended for use in interventional cardiology and vascular procedures. Cleared under FDA 510(k) (K915421) via the Traditional pathway, it adheres to Class 2 Cardiovascular regulatory standards. No MRI safety or reusable specifications are noted in the regulatory data.

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