510(k) K955002

MAHURKAR 8 FR DUAL LEMEN CATHETER by Quinton, Inc. — Product Code MPB

K955002 is an FDA 510(k) premarket notification submitted by Quinton, Inc. for the device "MAHURKAR 8 FR DUAL LEMEN CATHETER". The FDA issued a decision of Substantially Equivalent on September 13, 1996. The device falls under product code MPB (Catheter, Hemodialysis, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. Quinton, Inc. has at least 10 other 510(k) clearances on record.