510(k) Report

Devices descending from K182443

2 later devices reach Pristine Hemodialysis Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.20211—
+2K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—