510(k) K032061

DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH by Spire Biomedical, Inc. — Product Code MSD

K032061 is an FDA 510(k) premarket notification submitted by Spire Biomedical, Inc. for the device "DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH". The FDA issued a decision of Substantially Equivalent (kit) on December 23, 2003. 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.