Cleared Traditional

Umbilical Vessels Catheter

K201697 · Haolang Medical USA Corporation · General Hospital
May 2021
Decision
318d
Days
Class 2
Risk

About This 510(k) Submission

K201697 is an FDA 510(k) clearance for the Umbilical Vessels Catheter, a Catheter, Umbilical Artery (Class II — Special Controls, product code FOS), submitted by Haolang Medical USA Corporation (Bellevue, US). The FDA issued a Cleared decision on May 6, 2021, 318 days after receiving the submission on June 22, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K201697 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2020
Decision Date May 06, 2021
Days to Decision 318 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FOS — Catheter, Umbilical Artery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5200

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