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Vascular Access Port Changes in Mater LJT

by Norfolk Medical Products, Inc.

510(k) K840788

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 NumberK840788 Date24 Apr 1984ClearedStatusActive

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  • Withdrawn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)

Full name
Vascular Access Port Changes in Mater
510(k) Number
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.

The Vascular Access Port Changes in Mater LJT is a subcutaneous, implanted port designed for intravascular access. It serves as a long-term vascular access device, allowing repeated intravenous injections, infusions, or blood draws without repeated needle insertions into veins.

This device is supplied sterile and intended for single-use implantation. It is classified as a Class II medical device under FDA regulations and was cleared via a 510(k) submission (K840788). The port is intended for use in general hospital settings and adheres to regulatory standards outlined in 21 CFR 880.5965. No MRI safety information or reusable specifications are provided in the data.

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