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IMPLANTOFIX

by Burron Medical Products, Inc.

510(k) K851293

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 NumberK851293 Date9 Jan 1986ClearedStatusActive

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  • Withdrawn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, 24 Sep 2026

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

IMPLANTOFIX is an implanted port and catheter device designed for subcutaneous and intravascular use. It is a Class II medical device that provides vascular access for administration of medications, fluids, or blood products.

The device is supplied as a single-use product and is regulated under FDA 510(k) clearance with product code LJT. IMPLANTOFIX is manufactured by Burron Medical Products, Inc. and is intended for use in general hospital settings. The device is not MRI compatible and requires sterile storage conditions.

Other devices from Burron Medical Products, Inc.

See all devices from Burron Medical Products, Inc. →

Questions

AI-generated answers, 24 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 IMPLANTOFIX device used for?

    IMPLANTOFIX is an implanted port and catheter device designed for subcutaneous and intravascular use. It provides vascular access for administration of medications, fluids, or blood products in general hospital settings.

  • Is the IMPLANTOFIX device reusable or single-use?

    The IMPLANTOFIX device is supplied as a single-use product. It is not designed to be reused and should be discarded after a single procedure to ensure patient safety and device integrity.

  • What are the storage requirements for IMPLANTOFIX?

    IMPLANTOFIX requires sterile storage conditions. The device should be stored in a clean, dry environment that maintains sterility until it is ready for use in a clinical setting.

  • Is IMPLANTOFIX MRI compatible?

    No, IMPLANTOFIX is not MRI compatible. The device should not be used in patients undergoing MRI procedures as it may pose safety risks or interfere with the imaging process.