510(k) K980466

PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA by Sims Portex, Inc. — Product Code JOH

K980466 is an FDA 510(k) premarket notification submitted by Sims Portex, Inc. for the device "PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA". The FDA issued a decision of Substantially Equivalent on February 24, 1998. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Sims Portex, Inc. has at least 10 other 510(k) clearances on record.