510(k) Report

Devices descending from K973046

10 later devices reach Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171939ALVUE Balloon Dilation SystemGlobus Medical, Inc.20180—
+1K090631Pajunk Disposable Balloons and Balloon SystemsPAJUNK GmbH Medizintechnologie20099—
+2K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd.20107—
+3K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc.201062
+4K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc.2012415
+4K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc.20115—
+5K143743ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc.20152—
+5K130968Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc.201334
+6K170294VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST…C. R. Bard20171—
+7K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—