510(k) Report

Devices descending from K013162

5 later devices reach 14F X 24CM Ash Split-Cath,14F X 28CM Ash Split-Cath, 14F X 32CM Ash… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K02093610F X 18CM Pediatric Ash Split Cath XL, Model ASPC18P-XL; 10F X 24CM Pediatric Ash…Medcomp20023—
+1K02031514F X 55CM Ash Split-Cath XL, Model ASPC55-XLMedcomp20020—
+2K200627GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc.20202—
+3K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc.20201—
+4K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—