510(k) K071145

NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE by Nipro Medical Corporation — Product Code MPB

K071145 is an FDA 510(k) premarket notification submitted by Nipro Medical Corporation for the device "NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE". The FDA issued a decision of Substantially Equivalent on September 7, 2007. The device falls under product code MPB (Catheter, Hemodialysis, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. Nipro Medical Corporation has at least 10 other 510(k) clearances on record.