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Temp. Repair Kit-Dual Lumen Catheter

by Norton Performance Plastics Corp.

510(k) K831587

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 NumberK831587 Date19 Oct 1983ClearedStatusActive

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  • Withdrawn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
LJS
Device Class
Class II
Regulation
21 CFR Part 880.5970
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 Temp. Repair Kit-Dual Lumen Catheter is a Class 2 intravascular therapeutic catheter designed for long-term use greater than 30 days. It is manufactured by Norton Performance Plastics Corp. and is intended for temporary repair applications in a general hospital setting.

This device is supplied as part of a repair kit and is regulated under FDA 510(k) clearance K831587 with a product code of LJS. The catheter is classified for general hospital use and was cleared on August 11, 1983, as substantially equivalent.

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