510(k) K121614

NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER by Boston Scientific Corp — Product Code LJE

K121614 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on September 18, 2012. The device falls under product code LJE (Catheter, Nephrostomy), a Class U device. Boston Scientific Corp has at least 10 other 510(k) clearances on record.