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Lifeport Vascular Access Port

by Strato Medical Corp.

510(k) K895689

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 NumberK895689 Date27 Dec 1989ClearedStatusActive

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  • Withdrawn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, 21 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 Lifeport Vascular Access Port is an implanted, subcutaneous, intravascular port and catheter device designed for vascular access. It provides a subcutaneous access point for medical procedures requiring repeated vascular entry.

This device is supplied as a single-use or reusable product depending on the specific model and is intended for use in a hospital setting. The Lifeport Vascular Access Port is MRI safe and available in various sizes as specified by the manufacturer. It has received FDA 510(k) clearance with the product code LJT and is classified as a Class II medical device.

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Questions

AI-generated answers, 21 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 Lifeport Vascular Access Port used for?

    The Lifeport Vascular Access Port is an implanted, subcutaneous, intravascular port and catheter device designed for vascular access. It provides a subcutaneous access point for medical procedures requiring repeated vascular entry in a hospital setting.

  • Is the Lifeport Vascular Access Port single-use or reusable?

    The Lifeport Vascular Access Port is supplied as either a single-use or reusable product depending on the specific model selected by the healthcare provider for their clinical needs.

  • What sizes are available for the Lifeport Vascular Access Port?

    The Lifeport Vascular Access Port is available in various sizes as specified by the manufacturer, allowing clinicians to select the appropriate model for their patients' specific anatomical and clinical requirements.

  • What is the regulatory status of the Lifeport Vascular Access Port?

    The Lifeport Vascular Access Port has received FDA 510(k) clearance with the product code LJT and is classified as a Class II medical device, indicating it meets specific safety and effectiveness requirements.