510(k) K964369

TRACH CARE SET WITH MICROBAN by Ballard Medical Products — Product Code BSY

K964369 is an FDA 510(k) premarket notification submitted by Ballard Medical Products for the device "TRACH CARE SET WITH MICROBAN". The FDA issued a decision of Substantially Equivalent on February 11, 1997. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Ballard Medical Products has at least 10 other 510(k) clearances on record.