510(k) K993149

PERITONEAL DIALYSIS CATHETERS AND ADAPTERS by Medionics International, Inc. — Product Code FJS

K993149 is an FDA 510(k) premarket notification submitted by Medionics International, Inc. for the device "PERITONEAL DIALYSIS CATHETERS AND ADAPTERS". The FDA issued a decision of Substantially Equivalent on April 28, 2000. The device falls under product code FJS (Catheter, Peritoneal, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Medionics International, Inc. has at least 9 other 510(k) clearances on record.