510(k) Report

Devices descending from K061727

6 later devices reach Gore Preclude Vessel Guard through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101805Hydrofix Vaso ShieldMimedx Group, Inc.20110—
+1K103558Synthes Scout Vessel GuardSynthes Spine20111—
+1K090637Cardio-WrapMast Biosurgery USA, Inc.20100—
+1K082782Replication Medical Vessel GuardReplication Medical, Inc.20093—
+2K111048Synthes Scout Tack FixationSynthes Spine20120—
+2K100984Xylos Vessel GuardXylos Corporation20100—