510(k) K042359

SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL by Medical Designs, LLC — Product Code JXG

K042359 is an FDA 510(k) premarket notification submitted by Medical Designs, LLC for the device "SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL". The FDA issued a decision of Substantially Equivalent on November 17, 2004. 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.