510(k) K030209

MAHURKAR OPLUS CATHETER, MODEL 13.5 FR by The Kendall Company — Product Code MPB

K030209 is an FDA 510(k) premarket notification submitted by The Kendall Company for the device "MAHURKAR OPLUS CATHETER, MODEL 13.5 FR". The FDA issued a decision of Substantially Equivalent on May 13, 2003. The device falls under product code MPB (Catheter, Hemodialysis, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. The Kendall Company has at least 10 other 510(k) clearances on record.