510(k) K022000

POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES) by Spire Biomedical, Inc. — Product Code MSD

K022000 is an FDA 510(k) premarket notification submitted by Spire Biomedical, Inc. for the device "POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES)". The FDA issued a decision of Substantially Equivalent on July 19, 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.