510(k) K990949

CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT by Intersurgical, Inc. — Product Code CAH

K990949 is an FDA 510(k) premarket notification submitted by Intersurgical, Inc. for the device "CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT". The FDA issued a decision of Substantially Equivalent on June 15, 1999. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Intersurgical, Inc. has at least 10 other 510(k) clearances on record.