510(k) Report

Devices descending from K162228

2 later devices reach TorqVue Low Profile Delivery Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott20260—
+1K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)Abbott Medical20250—