510(k) K950042

SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER by Accurate Surgical Instruments Co. — Product Code FJS

K950042 is an FDA 510(k) premarket notification submitted by Accurate Surgical Instruments Co. for the device "SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER". The FDA issued a decision of Substantially Equivalent on December 15, 1995. 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.