510(k) Report

Devices descending from K080757

7 later devices reach Amplatzer Torqvue Low Profile Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131063Amplatzer Torq Vue LP Delivery SystemSt Jude Medical201351
+1K091793Amplatzer Torqvue 3 Delivery Sheath, Model 9-TV3-08F104, 9-TV3-08F54Aga Medical Corp.20090—
+2K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott20260—
+2K241538TriClip Steerable Guide CatheterAbbott Medical20241—
+2K162228TorqVue Low Profile Delivery CatheterAga Medical Corporation (Wholly Owned by St.Jude Medical Cor201621
+3K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)Abbott Medical20250—
+3K243224MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter…Abbott Medical20240—