510(k) Report

Devices descending from K060289

4 later devices reach Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091958Belfort-Dildy Obstetric Tamponade SystemGlenveigh Surgical, LLC20102—
+1K093904Glenveigh Vaginal Tamponade Balloon CatheterGlenveigh Surgical, LLC20100—
+2K150573ebb Complete Tamponade SystemClinical Innovations, LLC201511
+3K153591ebb Complete Tamponade SystemClinical Innovations, LLC20160—