510(k) Report

Devices descending from K163233

13 later devices reach MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192558Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter…Mivi Neurovascular20202—
+1K180201Route 92 Medical Access SystemRoute 92 Medical, Inc.20189—
+2K222948Q Distal Access CatheterMivi Neuroscience, Inc.20230—
+2K212402MIVI Q Distal Access CatheterMivi Neuroscience, Inc.20210—
+2K200121Route 92 Medical 088 Access System, 110 cmRoute 92 Medical, Inc.20208—
+3K242051VersaD Delivery CatheterUnity Medical, Inc.20251—
+3K201518Route 92 Medical 088 Access SystemRoute 92 Medical20205—
+4K251372VersaD Delivery CatheterUnity Medical, Inc.20250—
+4K210635Route 92 Medical Full Length 088 Access SystemRoute 92 Medical, Inc.20213—
+4K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc.20200Class I
+5K222743Route 92 Medical Full Length 070 Access SystemRoute 92 Medical, Inc.20222Class I
+6K231583Route 92 Medical Full Length 054 Access SystemRoute 92 Medical, Inc.20231—
+7K260220Route 92 Medical Full Length 046 Access SystemRoute 92 Medical, Inc.20260—