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V.A.D. Access Kit

by Clinipad Corp.

510(k) K932010

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 NumberK932010 Date3 Feb 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  • Withdrawn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, 22 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 V.A.D. Access Kit is a Port & Catheter, Implanted, Subcutaneous, Intravascular device intended for general hospital use. It is classified as a Class 2 medical device under FDA regulation number 880.5965 with product code LJT.

The device received FDA 510(k) clearance (K932010) through the Traditional pathway on February 3, 1994, after being found substantially equivalent to a predicate device. It is manufactured by Clinipad Corp. and supplied as a kit for vascular access procedures.

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Questions

AI-generated answers, 22 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 V.A.D. Access Kit used for?

    The V.A.D. Access Kit is intended for general hospital use as an implanted subcutaneous intravascular port and catheter system to provide vascular access for medical procedures such as infusion, blood withdrawal, or pressure monitoring.

  • How is the V.A.D. Access Kit supplied and is it reusable?

    The V.A.D. Access Kit is supplied as a complete kit for vascular access procedures and is designed for single-use implantation; it is not intended for reuse after explantation due to infection risk and material degradation.

  • What regulatory pathway was used for the V.A.D. Access Kit and when was it cleared?

    The V.A.D. Access Kit received FDA 510(k) clearance through the Traditional pathway on February 3, 1994, under K932010, after being determined substantially equivalent to a predicate device.