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Port-A-Cath

by Pharmacia, Inc.

510(k) K832917

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 NumberK832917 Date28 Dec 1983ClearedStatusActive

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  • Withdrawn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, 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.

A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. It is used for repeated access to the vascular system for infusion of fluids, medications, or blood products, and for withdrawal of blood samples.

The device is supplied as an implantable system intended for long-term vascular access. It is regulated as a Class 2 medical device under product code LJT, with FDA 510(k) clearance K832917, and is indicated for use in general hospital settings.

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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 is the PORT-A-CATH device used for?

    The PORT-A-CATH is used for repeated access to the vascular system to infuse fluids, medications, or blood products, and for withdrawal of blood samples, providing long-term vascular access in general hospital settings.

  • How is the PORT-A-CATH supplied and intended for use?

    The device is supplied as an implantable system intended for long-term vascular access, consisting of a subcutaneous implanted reservoir connected to a long-term intravascular catheter for repeated clinical use.

  • Is the PORT-A-CATH a single-use or reusable device?

    The PORT-A-CATH is designed as an implantable system for long-term use, meaning it is not single-use but intended to remain implanted and accessed repeatedly over time via needle puncture of the septum.