510(k) Report

Devices descending from K990803

6 later devices reach Medisystems Buttonhole Needle Sets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K134019Medisystems Onesite Dual Lumen Needle with Masterguard Anti-Stick Needle Protector…Nxstage Medical, Inc.20140—
+1K130873Vwing Vascular Needle Guide, 4MM X 07MM; Vwing Vascular Needle Guide, 6MM X 07MM; Vwing…Vital Access20130—
+1K082882A.V. Fistula Blunt Needle SetJms North America Corp.20092—
+1K063368Nipro Biohole NeedleNipro Medical Corp.20070—
+2K093637JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300…Jms North America Corp.20101—
+3K151017JMS Harmony A.V. Fistula Needle SetJMS North America Corporation20150—