510(k) K041006

TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR by Kendall — Product Code MSD

K041006 is an FDA 510(k) premarket notification submitted by Kendall for the device "TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR". The FDA issued a decision of Substantially Equivalent on May 19, 2004. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Kendall has at least 10 other 510(k) clearances on record.