510(k) Report

Devices descending from K060155

3 later devices reach 15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073093Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models DEC19SH24…Spire Biomedical, Inc.20080—
+1K06344115.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32…Spire Biomedical, Inc.2007048
+1K06343115.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28…Spire Biomedical, Inc.2007048