Cleared Traditional

Arterial Catheter

K201726 · Haolang Medical USA Corporation · Cardiovascular
Jul 2021
Decision
379d
Days
Class 2
Risk

About This 510(k) Submission

K201726 is an FDA 510(k) clearance for the Arterial Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Haolang Medical USA Corporation (Bellevue, US). The FDA issued a Cleared decision on July 7, 2021, 379 days after receiving the submission on June 23, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K201726 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2020
Decision Date July 07, 2021
Days to Decision 379 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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