510(k) K210833

Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula by Smiths Medical Asd, Inc. — Product Code JOH

K210833 is an FDA 510(k) premarket notification submitted by Smiths Medical Asd, Inc. for the device "Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula". The FDA issued a decision of Substantially Equivalent on November 26, 2021. 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.