Cleared Traditional

PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA

K041348 · Smiths Medical · Anesthesiology
Jul 2004
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K041348 is an FDA 510(k) clearance for the PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA, a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Smiths Medical (Hythe, Kent, GB). The FDA issued a Cleared decision on July 13, 2004, 54 days after receiving the submission on May 20, 2004. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K041348 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2004
Decision Date July 13, 2004
Days to Decision 54 days
Submission Type Traditional
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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