Skip to content

Norton Jugular Kits

by Norton Performance Plastics Corp.

510(k) K820581

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 NumberK820581 Date18 Mar 1982ClearedStatusActive

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  • Withdrawn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
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Norton Jugular Kits are cardiovascular medical devices designed for clinical use. These kits are categorized under product code DYB.

This device received FDA 510(k) clearance on March 18, 1982. It is manufactured by Norton Performance Plastics Corp. and is identified by the submission number K820581.

Other devices from Norton Performance Plastics Corp.

See all devices from Norton Performance Plastics Corp. →

Questions

AI-generated answers, 25 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 intended use of the Norton Jugular Kits?

    The Norton Jugular Kits are cardiovascular medical devices designed for clinical use in a medical setting.

  • What is the regulatory status of this device?

    This device received FDA 510(k) clearance on March 18, 1982, under submission number K820581, and is categorized under product code DYB.

  • Who is the manufacturer of the Norton Jugular Kits?

    The kits are manufactured by Norton Performance Plastics Corp., located in McHenry, Illinois.