510(k) K925508

RUSCH SAFETY CLEAR PLUS CUFFED W/MAGILL TIP by Rusch, Inc. — Product Code BTR

K925508 is an FDA 510(k) premarket notification submitted by Rusch, Inc. for the device "RUSCH SAFETY CLEAR PLUS CUFFED W/MAGILL TIP". The FDA issued a decision of Substantially Equivalent on September 2, 1993. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Rusch, Inc. has at least 10 other 510(k) clearances on record.