510(k) K040509

ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 by Spire Biomedical, Inc. — Product Code MSD

K040509 is an FDA 510(k) premarket notification submitted by Spire Biomedical, Inc. for the device "ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40". The FDA issued a decision of Substantially Equivalent on April 19, 2004. 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.