510(k) K060155

15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS by Spire Biomedical, Inc. — Product Code MSD

K060155 is an FDA 510(k) premarket notification submitted by Spire Biomedical, Inc. for the device "15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS". The FDA issued a decision of Substantially Equivalent on May 9, 2006. 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.