510(k) K121007

NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 by Delta Med Srl — Product Code FOZ

K121007 is an FDA 510(k) premarket notification submitted by Delta Med Srl for the device "NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1". The FDA issued a decision of Substantially Equivalent on December 28, 2012. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Delta Med Srl has at least 3 other 510(k) clearances on record.