510(k) K022620

SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT by Spire Biomedical, Inc. — Product Code FKA

K022620 is an FDA 510(k) premarket notification submitted by Spire Biomedical, Inc. for the device "SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT". The FDA issued a decision of Substantially Equivalent on October 11, 2002. The device falls under product code FKA (Dilator, Vessel), a Class II device regulated under 21 CFR 876.5540. Spire Biomedical, Inc. has at least 10 other 510(k) clearances on record.