510(k) K862046

SWAN-NECK PERITONEAL DIALYSIS CATHETERS by Accurate Surgical Instruments Co. — Product Code FJS

K862046 is an FDA 510(k) premarket notification submitted by Accurate Surgical Instruments Co. for the device "SWAN-NECK PERITONEAL DIALYSIS CATHETERS". The FDA issued a decision of Substantially Equivalent on June 19, 1986. The device falls under product code FJS (Catheter, Peritoneal, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Accurate Surgical Instruments Co. has at least 8 other 510(k) clearances on record.