Cleared Traditional

Wei Nasal Jet Tube

K211543 · Well Lead Medical Co., Ltd. · Anesthesiology
Jul 2022
Decision
428d
Days
Class 2
Risk

About This 510(k) Submission

K211543 is an FDA 510(k) clearance for the Wei Nasal Jet Tube, a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Well Lead Medical Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on July 21, 2022, 428 days after receiving the submission on May 19, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K211543 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2021
Decision Date July 21, 2022
Days to Decision 428 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTR — Tube, Tracheal (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5730

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