Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Hemodialysis Catheter

K-Number: K241581 · 2025-05-16

ApplicantHaolang Medical USA Corporation
Decision Date2025-05-16
Product CodeMSD
Advisory CommitteeGU
DecisionUnknown

Device Summary

Hemodialysis 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 2025-05-16 under 510(k) number K241581. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Hemodialysis Catheter?

Hemodialysis Catheter is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Haolang Medical USA Corporation. The 510(k) number is K241581.

When did Hemodialysis Catheter receive FDA 510(k) clearance?

Hemodialysis Catheter received FDA 510(k) clearance on 2025-05-16, under 510(k) number K241581.

Who is the listed applicant for Hemodialysis 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 Hemodialysis Catheter?

The FDA product code for Hemodialysis Catheter is MSD.

Related Clinical Trials

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.

NCT07019610Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled TrialNOT_YET_RECRUITINGNCT07655544Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard CathetersNOT_YET_RECRUITING

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.

K201726Arterial CatheterK201697Umbilical Vessels Catheter

Related Devices (Code: MSD)

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.

K210461End CapMedical Components Inc (Medcomp)K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc.K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMedical Components, Inc. (dba MedComp)

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.

↑