Cleared Special

Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set

K193133 · Cook Incorporated · Anesthesiology
Dec 2019
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K193133 is an FDA 510(k) clearance for the Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set, a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on December 12, 2019, 30 days after receiving the submission on November 12, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K193133 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2019
Decision Date December 12, 2019
Days to Decision 30 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code JOH — Tube Tracheostomy And Tube Cuff
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5800

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