Vascular-Access-Port Withdrawl-Blood LJT

by Norfolk Medical Products, Inc.

510(k) K841679

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

510(k) K841679↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK841679	Date28 Jun 1984Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name: Vascular-Access-Port Withdrawl-Blood

510(k) Number: K841679
FDA Product Code: LJT

Device Class: Class II
Regulation: 21 CFR Part 880.5965
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

This device is a Port & Catheter, Implanted, Subcutaneous, Intravascular, designed for vascular access to facilitate blood withdrawal. It is a subcutaneous implantable port system used to provide reliable and repeated access to the venous system for therapeutic or diagnostic procedures requiring phlebotomy.

The Vascular-Access-Port Withdrawl-Blood LJT is intended for single-use implantation and is regulated under FDA 510(k) clearance (K841679) as substantially equivalent to a predicate device. It is supplied sterile and intended for use in general hospital settings, adhering to medical specialty standards for vascular access solutions. The device is classified under regulation number 880.5965 and is not intended for reusable applications.

From the manufacturer

From the first human implant of a vascular access port (VAP) in 1982, to the first omni-directional access port in 1991, to the dynamic TidalPort™ of today, Norfolk Medical has pioneered innovative, cost-effective access solutions.

Source: norfolkmedical.com