510(k) K120985

KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING by Kimberly-Clark Corp. — Product Code BTR

K120985 is an FDA 510(k) premarket notification submitted by Kimberly-Clark Corp. for the device "KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING". The FDA issued a decision of Substantially Equivalent on December 19, 2012. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Kimberly-Clark Corp. has at least 10 other 510(k) clearances on record.