510(k) K023922

COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197 by Coapt Systems, Inc. — Product Code HWC

K023922 is an FDA 510(k) premarket notification submitted by Coapt Systems, Inc. for the device "COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197". The FDA issued a decision of Substantially Equivalent on December 20, 2002. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Coapt Systems, Inc. has at least 10 other 510(k) clearances on record.