Hemodialysis Catheter

FDA 510(k) K241581 · Haolang Medical USA Corporation

Unknown

510(k) numberK241581

Submission

Device name
Hemodialysis Catheter
Applicant
Haolang Medical USA Corporation
Bellevue, WA, US
Received
June 3, 2024
Decision date
May 16, 2025
Decision
Unknown (SESK)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MSD – Catheter, Hemodialysis, Implanted
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5540
Specialty
Gastroenterology, Urology
Implant
Yes
Life-sustaining
Yes

Other 510(k)s with product code MSD

510(k)DeviceApplicantDecision
K210461End CapMSD · Traditional Medical Components Inc (Medcomp)09/14/2021SE
K203575GlidePath Retro Long-Term Hemodialysis CatheterMSD · Traditional C.R. Bard, Inc.07/01/2021SESK
K211410GlidePath 13F Long-Term Hemodialysis CatheterMSD · Special Bard Peripheral Vascular, Inc.06/04/2021SESK
K203767Pristine Long-Term Hemodialysis CatheterMSD · Traditional C B Bard, Inc.04/02/2021SESK
K202150GlidePath 7.5F Long-Term Dialysis CatheterMSD · Traditional C.R. Bard, Inc.11/18/2020SESK
K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMSD · Special Medical Components, Inc. (dba MedComp)09/03/2020SE
K200627GlidePath 10F Long-Term Dialysis CatheterMSD · Traditional C.R. Bard, Inc.06/22/2020SESK
K190527GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters…MSD · Traditional C. R. Bard03/05/2020SESK
K182443Pristine Hemodialysis CatheterMSD · Traditional Pristine Access Technologies , Ltd.05/31/2019SE
K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm…MSD · Traditional Medical Components, Inc. (dba MedComp)05/17/2018SESK

More from Medical Components, Inc. (dba MedComp)

510(k)DeviceDecision
K201726Arterial CatheterDQY · Traditional 07/07/2021SE
K201697Umbilical Vessels CatheterFOS · Traditional 05/06/2021SE

Questions and answers

When was Hemodialysis Catheter cleared by the FDA?

Hemodialysis Catheter (K241581) received a 510(k) decision of Unknown on May 16, 2025, 347 days after the submission was received.

What is the product code of K241581?

The FDA product code is MSD – Catheter, Hemodialysis, Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.