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Catco Umbilical Vessel Catheter

by Catco Medical, Inc.

510(k) K944336

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 NumberK944336 Date5 Apr 1995ClearedStatusActive

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  • Withdrawn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
FOZ
Device Class
Class II
Regulation
21 CFR Part 880.5200
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.

The Catco Umbilical Vessel Catheter is a short-term intravascular catheter designed for therapeutic use in neonatal and pediatric patients. It is intended for insertion into umbilical vessels to facilitate vascular access, fluid administration, or monitoring of hemodynamic parameters. Constructed as a single-lumen device, it is classified under the category of catheters for general hospital use.

This catheter is supplied as a sterile, single-use device and is regulated under FDA 510(k) clearance (K944336) with a product code of FOZ. It is intended for use in clinical settings requiring temporary vascular access, typically for less than 30 days. Storage and handling must comply with sterile medical device protocols to ensure patient safety and device integrity.

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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 Catco Umbilical Vessel Catheter used for?

    This catheter is designed for short-term intravascular use in neonatal and pediatric patients to provide vascular access, administer fluids, or monitor hemodynamic parameters through umbilical vessels. Its single-lumen design ensures targeted delivery while minimizing complications associated with prolonged insertion.

  • Is the Catco Umbilical Vessel Catheter sterile and single-use?

    Yes, the Catco Umbilical Vessel Catheter is supplied as a sterile, single-use device. Sterility is critical for neonatal and pediatric patients to prevent infection, and single-use ensures compliance with clinical protocols for minimizing cross-contamination risks.

  • How long is this catheter intended for use?

    The device is intended for temporary vascular access, typically for less than 30 days. This short-term use aligns with clinical needs for neonatal and pediatric patients requiring transient fluid administration or hemodynamic monitoring without prolonged catheterization.

  • What storage and handling precautions must be followed?

    The catheter must be stored and handled according to sterile medical device protocols to maintain its integrity and ensure patient safety. Improper storage could compromise sterility, leading to potential infection risks in vulnerable neonatal and pediatric patients.

  • What regulatory clearance does the Catco Umbilical Vessel Catheter hold?

    The device holds FDA 510(k) clearance under the reference number K944336, classified under product code FOZ for catheters used in general hospital settings. This clearance confirms its substantial equivalence to a legally marketed predicate device.