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Vasport Vascular Access Port

by Gish Biomedical, Inc.

510(k) K953571

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 NumberK953571 Date2 Oct 1995ClearedStatusActive

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  • Withdrawn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, 23 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 Vasport Vascular Access Port is an implanted, subcutaneous, intravascular port and catheter system. It is designed to provide vascular access for medical treatments.

This device is a Class 2 medical device regulated under the general hospital specialty. It has received FDA 510(k) clearance.

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See all devices from Gish Biomedical, Inc. →

Questions

AI-generated answers, 23 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 primary purpose of the Vasport Vascular Access Port?

    The Vasport is designed to provide reliable vascular access for patients requiring medical treatments. It functions as an implanted, subcutaneous, intravascular port and catheter system to facilitate the delivery of therapies.

  • How is the Vasport regulated?

    The Vasport is classified as a Class 2 medical device under the general hospital specialty. It has received FDA 510(k) clearance, which indicates that the device has been found to be substantially equivalent to other legally marketed devices.

  • Who is the manufacturer of this device?

    The Vasport Vascular Access Port is manufactured by Gish Biomedical, Inc., located in Irvine, California.