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Multilumen Central Venous Cath. W/Vitacuff Device

by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)

Active United States

510(k) K882448

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK882448 Date9 Aug 1988ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 19 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 multilumen central venous catheter with a Vitacuff component, classified as a catheter, intravascular, therapeutic, long-term greater than 30 days. It is intended for use in general hospital settings for vascular access.

The device is supplied as a single-use, sterile product and is regulated under FDA 510(k) clearance (K882448) with product code LJS. It received a substantially equivalent decision on August 9, 1988, and is subject to regulation number 880.5970.

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Questions

AI-generated answers, 19 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 purpose of the MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE?

    This device is a multilumen central venous catheter with a Vitacuff component, intended for vascular access in general hospital settings for therapeutic use longer than 30 days.

  • How is the MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE supplied?

    The device is supplied as a single-use, sterile product for patient safety and infection prevention purposes.

  • What is the regulatory status of this device?

    The device has FDA 510(k) clearance (K882448) with product code LJS and received a substantially equivalent decision on August 9, 1988.

  • Can this device be reused on multiple patients?

    No, this device is supplied as a single-use product and should not be reused on multiple patients to maintain sterility and prevent infection risks.