510(k) K041348

PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA by Smiths Medical — Product Code JOH

K041348 is an FDA 510(k) premarket notification submitted by Smiths Medical for the device "PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA". The FDA issued a decision of Substantially Equivalent on July 13, 2004. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Smiths Medical has at least 2 other 510(k) clearances on record.