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L-Cath Catheter System - Port L-Cath

by Luther Medical Products, Inc.

510(k) K942103

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 NumberK942103 Date26 Jul 1994ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 27 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 L-Cath Catheter System - Port L-Cath is a catheter system, classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular device. It is a medical device used in general hospital settings.

The device is supplied with FDA 510K authorizations and has a regulation number of 880.5965. It is classified as a class 2 device and has been assigned the product code LJT. The device has undergone an 85-day FDA review and has been determined to be substantially equivalent.

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Questions

AI-generated answers, 27 Sep 2026

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

  • What is the L-Cath Catheter System - Port L-Cath used for?

    The L-Cath Catheter System - Port L-Cath is used in general hospital settings for implanted, subcutaneous, intravascular use, and is classified as a Port & Catheter device.

  • What is the regulatory status of the L-Cath Catheter System - Port L-Cath?

    The device has undergone an 85-day FDA review and has been determined to be substantially equivalent, with an FDA 510K authorization and regulation number of 880.5965.

  • How is the L-Cath Catheter System - Port L-Cath supplied?

    The device is supplied with FDA 510K authorizations, and has been assigned the product code LJT, with a classification as a class 2 device.