FDA 510(k)

Umbilical Vessels Catheter

K-Number: K201697 · 2021-05-06

ApplicantHaolang Medical USA Corporation

Decision Date2021-05-06

Product CodeFOS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Umbilical Vessels Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Haolang Medical USA Corporation. It received FDA 510(k) clearance on 2021-05-06 under 510(k) number K201697. The device is classified under product code FOS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Umbilical Vessels Catheter?

Umbilical Vessels Catheter is a medical device that received FDA 510(k) clearance on 2021-05-06. The listed applicant is Haolang Medical USA Corporation. The 510(k) number is K201697.

When did Umbilical Vessels Catheter receive FDA 510(k) clearance?

Umbilical Vessels Catheter received FDA 510(k) clearance on 2021-05-06, under 510(k) number K201697.

Who is the listed applicant for Umbilical Vessels Catheter?

The FDA 510(k) record lists Haolang Medical USA Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Umbilical Vessels Catheter?

The FDA product code for Umbilical Vessels Catheter is FOS.

Other records listing Haolang Medical USA Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241581Hemodialysis Catheter K201726Arterial Catheter

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.