510(k) Report

Devices descending from K032061

4 later devices reach Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073092Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models DE19SH24…Spire Biomedical, Inc.20080—
+1K04285855CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated TipsSpire Biomedical, Inc.2004148
+1K040509Alta LR Fixed Tip Chronic Hemodialysis Catheter, Models AL19NH24, AL23NH28, AL27NH32…Spire Biomedical, Inc.2004148
+2K06344115.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32…Spire Biomedical, Inc.2007048