510(k) K062435

REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS by Spire Biomedical, Inc. — Product Code NFK

K062435 is an FDA 510(k) premarket notification submitted by Spire Biomedical, Inc. for the device "REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS". The FDA issued a decision of Substantially Equivalent on December 5, 2006. The device falls under product code NFK (Kit, Repair, Catheter, Hemodialysis), a Class II device regulated under 21 CFR 876.5540. Spire Biomedical, Inc. has at least 10 other 510(k) clearances on record.