Fenestrated Infusion Catheter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K024190 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K060497 Active Cleared 11 Jul 2006

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• Infant Feeding Tubes

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  FDA 510(k) K031409 Active Cleared 17 Jun 2003

See all devices from Promedic, Inc. →

• What is the primary purpose of the Fenestrated Infusion Catheter?

  This device is designed for the dispersion of medication within a general hospital setting. It functions as an infusion pump accessory to facilitate controlled delivery.

• What are the available fenestration lengths for this catheter?

  The catheter features distal fenestrations that are available in three specific lengths: 1.5 inches, 3.0 inches, or 5.0 inches, allowing for clinical flexibility during medication administration.

• What are the physical dimensions of the catheter?

  The device is a 20-gauge, 30-inch small-bore tube. It is equipped with a standard Touhy Borst connector and includes shaft markings to assist clinicians with reference during use.

• What is the regulatory status of this infusion catheter?

  The Fenestrated Infusion Catheter is classified as a Class 2 infusion pump accessory. It has received FDA 510(k) clearance under the traditional pathway, as indicated by the K024190 submission.