510(k) Report

Devices descending from K010567

15 later devices reach Optiflow Catheter #5641190 Catheter Only #5643150 Catheter Kit #5631000… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030020Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc.200312—
+1K011916Super C Hemodialysis/Apheresis Chronic Catheter, Model DC-36 Series, DC-40 Series, DC-45…Horizon Medical Products, Inc.20011—
+2K090101Equistream Long-Term Hemodialysis CathetersC.R. Bard, Inc.2009015
+2K053589Long-Term Hemodialysis Catheters with Biobloc CoatingBard Access Systems, Inc.20061—
+2K051748Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis CathetersC.R. Bard, Inc.2005813
+2K033294Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with…C.R. Bard, Inc.200310—
+2K022905Lifejet F16 Hemodialysis/Apheresis Chronic CatheterHorizon Medical Products, Inc.20020—
+3K190527GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters…C. R. Bard20205—
+3K090528Duet Long-Term Hemodialysis Catheter System, Duet Long-Term Hemodialysis Catheter System…C.R. Bard, Inc.20090—
+3K063245Elutia Coated Closed Surgical Wound DrainBacterin International, Inc.200702
+4K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.20210—
+4K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.20210—
+4K200627GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc.20202—
+5K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc.20201—
+6K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—