510(k) Report

Devices descending from K974617

3 later devices reach Peripheral Vascular Dilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012256Gelbish Vascular DilatorVascumetrix, LLC20012—
+2K030260Gelbfish Flex Vascular DilatorVascumetrix, LLC20030—
+2K023507Modification to Gelbfish Vascular DilatorsVascumetrix, LLC20020—