510(k) K850214

STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN by Accurate Surgical Instruments Co. — Product Code FJS

K850214 is an FDA 510(k) premarket notification submitted by Accurate Surgical Instruments Co. for the device "STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN". The FDA issued a decision of Substantially Equivalent on July 26, 1985. 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.