Cleared Traditional

Hemodialysis Catheter

K241581 · Haolang Medical USA Corporation · Gastroenterology & Urology

May 2025

Decision

347d

Days

Class 2

Risk

About This 510(k) Submission

K241581 is an FDA 510(k) clearance for the Hemodialysis Catheter, a Catheter, Hemodialysis, Implanted (Class II — Special Controls, product code MSD), submitted by Haolang Medical USA Corporation (Bellevue, US). The FDA issued a Cleared decision on May 16, 2025, 347 days after receiving the submission on June 3, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number	K241581 FDA.gov
FDA Decision	Cleared SESK
Date Received	June 03, 2024
Decision Date	May 16, 2025
Days to Decision	347 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF