510(k) Report

Devices descending from K040509

1 later device reach Alta LR Fixed Tip Chronic Hemodialysis Catheter, Models AL19NH24, AL23NH28… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K06344115.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32…Spire Biomedical, Inc.2007048