510(k) K030788

KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS by Geister Medizin Technik GmbH — Product Code DWP

K030788 is an FDA 510(k) premarket notification submitted by Geister Medizin Technik GmbH for the device "KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS". The FDA issued a decision of Substantially Equivalent on July 12, 2003. The device falls under product code DWP (Dilator, Vessel, Surgical), a Class II device regulated under 21 CFR 870.4475. Geister Medizin Technik GmbH has at least 5 other 510(k) clearances on record.