510(k) K024270

CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3 by Intersurgical, Inc. — Product Code CAH

K024270 is an FDA 510(k) premarket notification submitted by Intersurgical, Inc. for the device "CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3". The FDA issued a decision of Substantially Equivalent on June 24, 2003. 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.