510(k) Report

Devices descending from K053491

106 later devices reach Penumbra Balloon Guide Catheter, Model 7.5F through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration…Perfuze, Ltd.20243—
+8K231583Route 92 Medical Full Length 054 Access SystemRoute 92 Medical, Inc.20231—
+9K260220Route 92 Medical Full Length 046 Access SystemRoute 92 Medical, Inc.20260—
+9K253901Millipede88 Access CatheterPerfuze, Ltd.20260—
+9K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20251—
+10K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20250—