510(k) K863128

PERITONEAL DIALYSIS CATHETERS by Thermedics, Inc. — Product Code FJS

K863128 is an FDA 510(k) premarket notification submitted by Thermedics, Inc. for the device "PERITONEAL DIALYSIS CATHETERS". The FDA issued a decision of Substantially Equivalent on September 9, 1986. The device falls under product code FJS (Catheter, Peritoneal, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Thermedics, Inc. has at least 3 other 510(k) clearances on record.