510(k) Report

Devices descending from K031459

5 later devices reach Rapido Cut-Away Cutter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111252Acuity (TM) Cut-Away (TM) Guide Catheters 6F and 8FBoston Scientific Corp20113—
+1K080154Acuity Universal CutterCardiac Pacemakers, Inc.200801
+2K132914Acuity Pro Lead Delivery SystemBoston Scientific201421
+3K171612ACUITY Pro Lead Delivery SystemBoston Scientific Corporation20171—
+4K243757Shockwave CS Guide CatheterShockwave Medical, Inc.20250—