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Umbilical Vessels Catheter

by Haolang Medical USA Corporation

510(k) K201697

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 NumberK201697 Date6 May 2021ClearedStatusActive

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  • Withdrawn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
FOS
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

An umbilical vessels catheter is a medical device designed for neonates and infants who require medical intervention. It is inserted into the umbilical vein or artery to provide direct access to the circulatory system, allowing medical professionals to administer medications and fluids or obtain blood samples.

This device is supplied as a sterile, single-use catheter and is intended for use in general hospital settings. It has received FDA 510(k) clearance under K201697 and is classified as a Class II device under regulation number 880.5200 with product code FOS.

Other devices from Haolang Medical USA Corporation

Questions

AI-generated answers, 27 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 umbilical vessels catheter used for?

    It is designed for neonates and infants requiring medical intervention, providing direct access to the umbilical vein or artery to administer medications and fluids or obtain blood samples in general hospital settings.

  • Is the umbilical vessels catheter sterile and single-use?

    Yes, the device is supplied as a sterile, single-use catheter, meaning it is intended for one patient and one procedure only to maintain sterility and prevent cross-contamination.

  • What regulatory clearance does the umbilical vessels catheter have?

    It has received FDA 510(k) clearance under K201697 and is classified as a Class II medical device under regulation number 880.5200 with product code FOS.