510(k) K092451

INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER by Intersurgical, Inc. — Product Code CAH

K092451 is an FDA 510(k) premarket notification submitted by Intersurgical, Inc. for the device "INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER". The FDA issued a decision of Substantially Equivalent on October 29, 2010. 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.