510(k) Report

Devices descending from K093969

4 later devices reach Acuity Break-Away Guide Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132914Acuity Pro Lead Delivery SystemBoston Scientific201421
+1K111252Acuity (TM) Cut-Away (TM) Guide Catheters 6F and 8FBoston Scientific Corp20113—
+2K171612ACUITY Pro Lead Delivery SystemBoston Scientific Corporation20171—
+3K243757Shockwave CS Guide CatheterShockwave Medical, Inc.20250—