510(k) Report

Devices descending from K140034

2 later devices reach Surefire Guiding Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233858TriSalus TriGuideTM Guiding CatheterTrisalus Life Sciences20230—
+1K162359Surefire Guiding CatheterSurefire Medical, Inc.20160—