510(k) Report

Devices descending from K950597

3 later devices reach Core-Resistant Huber Infusion Set with Y-Site through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033515Huberpro Safety Huber Infusion SetCommand Medical Products20041—
+1K961495Huber Needle Extension Set with Standard Y-Injection Site, Interlink Y-Injection Site…Baxter Healthcare Corp199609
+2K083482Cook Vascular Vital-Ject Power Injectable Safety Infusion SetCook Vascular, Inc.20090—