FDA 510(k) Applications for Medical Device Product Code "FKA"
(Dilator, Vessel)

FDA 510(k) Number Applicant Device Name Decision Date
K022620 SPIRE BIOMEDICAL, INC. SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT 10/11/2002


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