510(k) Report

Devices descending from K013975

6 later devices reach CP-Sleeve through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K034062CP Sleeve and River SleeveCp Medical20045—
+2K103449Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold MakersRiverpoint Medical20113—
+2K061638Best Strand and Best SpacerBest Medical International, Inc.20060—
+3K131689Mri MarkerC4 Imaging, LLC20131—
+3K120859Pre-Loaded Gold Visicoil CK MarkerRadiomed Corporation20120—
+4K171487Sirius MRI Marker NSC4 Imaging, LLC20170—