510(k) Report

Devices descending from K002912

2 later devices reach Vaginal Port, Non-Sterile / 600065, Vaginal Port, Sterile / 600073 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092534Alatus Vaginal Balloon Packing SystemRadiadyne20091—
+2K120344Radiapak Brachytherapy Applicator Balloon DeviceRadiadyne, LLC (Specification Developer)20120—