510(k) Report

Devices descending from K132914

2 later devices reach Acuity Pro Lead Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171612ACUITY Pro Lead Delivery SystemBoston Scientific Corporation20171—
+2K243757Shockwave CS Guide CatheterShockwave Medical, Inc.20250—