510(k) K850247

PERITONEAL DIALYSIS COIL CATHETER by Sil-Med Corp. — Product Code FXX

K850247 is an FDA 510(k) premarket notification submitted by Sil-Med Corp. for the device "PERITONEAL DIALYSIS COIL CATHETER". The FDA issued a decision of Substantially Equivalent on February 14, 1985. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Sil-Med Corp. has at least 10 other 510(k) clearances on record.