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Luer Lock Skirt

by Hewlett-Packard Co. 510(k)

Active United States

510(k) K862451

Overview

The Luer Lock Skirt is a Luer Lock Fitting (per FDA nomenclature), a reusable connector designed to securely attach tubing, syringes, or other medical devices via a threaded Luer taper connection. It ensures a leak-proof seal and prevents accidental disconnection, commonly used in cardiopulmonary bypass systems and intravenous therapy.

This device is intended for reusable clinical use in sterile or semi-sterile settings, such as operating rooms or cardiac catheterization labs. Supplied as a standalone component, it must comply with FDA regulation 870.4290 and was granted FDA 510(k) clearance (K862451) under the Cardiovascular advisory committee. No MRI safety classification or single-use designation is specified.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK862451 Date31 Oct 1986ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DTL
Device Class
Class II
Regulation
21 CFR Part 870.4290
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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