510(k) Report

Devices descending from K945287

1 later device reach Inhealth Blom-Singer Indwelling Valved Insert Accessory Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082206Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series, DV-2000 SeriesHelix Medical, LLC20080—