510(k) Report

Devices descending from K132474

10 later devices reach Cardiovascular Pressure Measurement (CPM) System, Navvus Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190473ACIST RXi System and Navvus II CatheterAcist Medical Systems, Inc.20191—
+1K141275Endophys Pressure Sensing Sheath KitEndophys, Inc.20154—
+1K141615Endophys Blood Pressure MonitorEndophys, Inc.20152—
+2K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc.20240—
+2K160945Endophys Blood Pressure MonitorEndophys Holdings, LLC20161—
+2K160272Endophys Pressure Sensing Sheath KitEndophys, Inc.20163—
+3K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLC20230—
+3K180620Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC20180—
+3K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC20171—
+4K190098Endophys Pressure Sensing SheathEndophys Holdings, LLC20190—