510(k) K063441

15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 by Spire Biomedical, Inc. — Product Code MSD

K063441 is an FDA 510(k) premarket notification submitted by Spire Biomedical, Inc. for the device "15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55". The FDA issued a decision of Substantially Equivalent on February 12, 2007. 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.