510(k) K961392

ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II by Sil-Med Corp. — Product Code FJS

K961392 is an FDA 510(k) premarket notification submitted by Sil-Med Corp. for the device "ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II". The FDA issued a decision of Substantially Equivalent on July 18, 1997. The device falls under product code FJS (Catheter, Peritoneal, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Sil-Med Corp. has at least 10 other 510(k) clearances on record.