510(k) K170720

Portex Blue Line Ultra Paediatric Tracheosomy Tube by Smiths Medical Asd, Inc. — Product Code JOH

K170720 is an FDA 510(k) premarket notification submitted by Smiths Medical Asd, Inc. for the device "Portex Blue Line Ultra Paediatric Tracheosomy Tube". The FDA issued a decision of Substantially Equivalent on December 7, 2017. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Smiths Medical Asd, Inc. has at least 10 other 510(k) clearances on record.