510(k) Report

Devices descending from K913636

7 later devices reach Orbis-Sigma Valve System for Ventricular Shunting through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971799Precision Flow Osv IIElekta Implants, SA19985—
+1K955265Cordis Sharp-Ended Stylet; Blunt-Ended Stylet; Cyst Puncture CatheterCordis Corp.19960—
+2K092395Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve SystemIntegra Lifesciences Corp.20091—
+2K081773OSV IIIntegra Neurosciences Implants S.A.20082—
+2K042192Low Flow Osv II Hydrocephalus ValveIntegra Neurosciences Implants S.A.20043—
+3K140722Integra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve…Integra LifeSciences Corporation20150—
+3K093968Osv II Low Flow Low Pro ValveIntegra LifeSciences Corporation20101—