510(k) Report

Devices descending from K082997

4 later devices reach Terumo Hybria Closed System Safety I.V. Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100282Terumo Surshield- Pur Safety I.V. CatheterTerumo Corp.20103—
+2K123267Surfflash (R) Plus Safety I.V. CatheterKofu Factory of Terumo Corp.20120—
+2K122544Terumo Surflash Safety I.V. CatheterTerumo Corporation20121—
+3K141138Surflash Safety I.V. CatheterKofu Factory of Terumo Corp.20140—