510(k) Report

Devices descending from K002210

10 later devices reach Syntra Dialyzer, Model Syntra 120, 160 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160558Rapido Hollow-Fibre DialyzersBellco Srl20160—
+1K023664Syntra + Dialyzer, Model 200Baxter Healthcare Corp20030—
+1K014152Nxstage Cartridge ExpressNxstage Medical, Inc.20027—
+2K032356Nxstage System One with Cartridge ExpressNxstage Medical, Inc.20036—
+3K050727Modification to Nxstage Cartridge ExpressNxstage Medical, Inc.20055—
+4K061837Nxstage Cartridge ExpressNxstage Medical, Inc.200641
+5K232803NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)Nxstage Medical, Inc.20240—
+5K183158NxStage Cartridge Express with SpeedswapNxstage Medical, Inc.201901
+5K131050Nxstage 1.6M2 DialyzerNxstage Medical, Inc.20130—
+5K123395Nxstage System One Low Volume Cartridge ExpressNxstage Medical, Inc.20130—