Match the change to a 510(k) device/new submission for a 510(k) device with the appropriate regulatory pathway. Remember to use the FDA guidance on 510(k) changes and types of 510(k) submissions before responding. Use each response only once. new catheter material using a material previously used by the manufacturer in a similar device a) 510(k) changes being effected b) traditional 510(k) c) abbreviated 510(k) d) letter to file