Skip to content

Strato Plastic Port Intro(9 Fr)LPS 7513/MODIFIED

by Strato Medical Corp.

510(k) K905850

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)SESK Substantially Equivalent — Kit · Traditional NumberK905850 Date19 Apr 1991ClearedStatusActive

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  • Withdrawn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
SESK Substantially Equivalent — Kit

Overview

AI-generated summary, 1 Oct 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 subcutaneous implanted port and catheter system, consisting of a portal body with a resealable septum and outlet made of metal, plastic, or a combination of these materials, and a long-term intravascular catheter that is either preattached or attached at the time of placement. It is designed for repeated access to the vascular system for infusion, withdrawal, or monitoring of fluids.

The device is supplied sterile and intended for single-use implantation. It is indicated for use in general hospital settings and has received FDA 510(k) clearance under K905850. The product code is LJT, and it is classified as a Class II medical device.

Other devices from Strato Medical Corp.

See all devices from Strato Medical Corp. →

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical purpose does the STRATO PLASTIC PORT INTRO(9 FR)LPS 7513 serve?

    It provides a permanent subcutaneous access point to the vascular system, allowing clinicians to repeatedly infuse, withdraw, or monitor fluids without repeated needle sticks, which improves patient comfort and reduces procedural risk.

  • How is the device supplied and intended for use?

    The system is supplied sterile in a single‑use package, with the portal body and catheter pre‑attached or attachable at implantation. It is meant for one‑time implantation and should not be reused after removal.

  • What materials are used in the portal and catheter, and why does that matter?

    The portal body incorporates a resealable septum made of metal, plastic, or a combination, while the catheter is constructed of compatible intravascular materials. These choices ensure durability for long‑term use, maintain sterility, and provide reliable fluid flow.

  • What regulatory pathway was followed for this device?

    The STRATO PLASTIC PORT INTRO(9 FR)LPS 7513 received traditional FDA 510(k) clearance (K905850) and is classified as a Class II device under product code LJT, indicating it met the necessary safety and performance standards for market entry.