510(k) K021212

24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS by Spire Biomedical, Inc. — Product Code MSD

K021212 is an FDA 510(k) premarket notification submitted by Spire Biomedical, Inc. for the device "24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS". The FDA issued a decision of Substantially Equivalent on May 17, 2002. 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.