510(k) K002970

SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 by Medical Designs, LLC — Product Code JXG

K002970 is an FDA 510(k) premarket notification submitted by Medical Designs, LLC for the device "SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901". The FDA issued a decision of Substantially Equivalent on December 12, 2000. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Medical Designs, LLC has at least 6 other 510(k) clearances on record.