510(k) Report

Devices descending from K080891

3 later devices reach Revolution 45MHZ Ivus Imaging Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipVolcano Corporation201602
+1K122826Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter Model 87000…Volcano Corporation20131—
+2K132659Volcano Preview Forward-Looking Ivus SystemVolcano Corporation20130—