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Vital-Port Vascular Access System Power Injectable Port

by Cook Vascular, Inc.

510(k) K081425

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK081425 Date30 Sep 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1223-2018 FDA Class II initiated 28 Nov 2017

    Non-coring needle provided with the Cook Vital-Port Vascular Assess System (Vital-Port) may cut or dislodge a core or sliver of material from the Vital-Port septum when the non-coring needle is inserted into the Vital-Port. This needle is used on the initial implant of the Vital-Port. Vital-Port products that have been successfully placed in patients are not impacted by this recall.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Cook Vascular Inc. Vital-Port Vascular Access System Power Injectable Port
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, 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.

The Vital-Port Vascular Access System Power Injectable Port is a subcutaneous, implanted, intravascular infusion port and catheter. It is designed for repeated vascular access, enabling infusion therapy, blood withdrawal, and power injection of contrast media during imaging procedures.

This device is supplied as a reusable, implanted system intended for use in general hospital settings. It is manufactured in a sterile condition and requires surgical implantation beneath the skin, with the catheter positioned intravascularly. The system is classified under FDA device class II and is authorised via FDA 510(k) clearance (K081425). Multiple registration numbers and FEI numbers are associated with its regulatory filing.

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