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Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power Gripper Plus Needle

by Smiths Medical MD, Inc.

510(k) K070116

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 NumberK070116 Date23 May 2007ClearedStatusActive

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  • Withdrawn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
Models / Variants
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.

This device is an implantable venous access system, specifically the Power Port-A-Cath and Power Port-A-Cath II, designed for subcutaneous, intravascular use. It includes an implanted port and catheter system intended for long-term vascular access, paired with the Power Gripper Plus needle for access and infusion procedures.

The system is supplied as a reusable implantable system with a single-use needle component. It is indicated for use in general hospital settings and has received FDA 510(k) clearance under product code LJT and regulation number 880.5965. The device is manufactured by Smiths Medical MD, Inc. and is classified as a Class II medical device.

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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 Power Port-A-Cath II system used for?

    The Power Port-A-Cath II system is designed for long-term vascular access in general hospital settings, providing subcutaneous, intravascular access for infusion therapies and blood draws via an implanted port and catheter paired with the Power Gripper Plus needle.

  • Is the Power Port-A-Cath II system reusable or single-use?

    The implanted port and catheter components of the Power Port-A-Cath II system are reusable for long-term access, while the Power Gripper Plus needle is a single-use component intended for each access procedure to maintain sterility and prevent cross-contamination.

  • What regulatory pathway was used for the Power Port-A-Cath II system?

    The Power Port-A-Cath II system received FDA 510(k) clearance under product code LJT and regulation number 880.5965, demonstrating substantial equivalence to a legally marketed predicate device through a traditional submission process.