510(k) Report

Devices descending from K001544

4 later devices reach Vaginal Applicator Shielded through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092534Alatus Vaginal Balloon Packing SystemRadiadyne20091—
+1K052351HDR Iort Shielded ApplicatorMick Radio-Nuclear Instruments, Inc.20051—
+2K120344Radiapak Brachytherapy Applicator Balloon DeviceRadiadyne, LLC (Specification Developer)20120—
+2K062135Art Shielded Breast ApplicatorAdvanced Radiation Therapy, LLC20060—