510(k) Report

Devices descending from K171109

6 later devices reach Praxiject 0.9% NaCl through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2012860.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9%…Nurse Assist, LLC20201Class I
+1K192414Praxiject 0.9% NaClMedxl, Inc.20203—
+2K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.20250—
+2K231754Praxiject™ 0.9% NaClMedxl, Inc.20231—
+2K214080PentaflushPentaferte Italia S.R.L.20220—
+3K233623Praxiject™ SP 0.9% NaClMedxl, Inc.20240—