510(k) Report

Devices descending from K034062

5 later devices reach CP Sleeve and River Sleeve through their predicates, nearest generation first.

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