510(k) K134019

MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO by Nxstage Medical, Inc. — Product Code FIE

K134019 is an FDA 510(k) premarket notification submitted by Nxstage Medical, Inc. for the device "MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO". The FDA issued a decision of Substantially Equivalent on September 11, 2014. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. Nxstage Medical, Inc. has at least 10 other 510(k) clearances on record.