510(k) K060288

RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS by Spire Biomedical, Inc. — Product Code MSD

K060288 is an FDA 510(k) premarket notification submitted by Spire Biomedical, Inc. for the device "RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS". The FDA issued a decision of Substantially Equivalent (kit) on September 1, 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.