510(k) K042858

55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS by Spire Biomedical, Inc. — Product Code MSD

K042858 is an FDA 510(k) premarket notification submitted by Spire Biomedical, Inc. for the device "55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS". The FDA issued a decision of Substantially Equivalent on December 3, 2004. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Spire Biomedical, Inc. has at least 10 other 510(k) clearances on record.