510(k) Report

Devices descending from K013721

14 later devices reach Synthetic Polysioprene Ultrasound Transducer Cover through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131528Non-Pyrogenic Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc.20131—
+1K091828Sheathesiso Ultrasound Transducer CoverSheathing Technologies, Inc.20090—
+1K041077Imalux Oct Probe GuideImalux Corporation200410—
+2K222460Intraoperative Ultrasound Probe CoverExact Medical Manufacturing20230—
+2K112770Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc.20119—
+3K162466LuminScan (TM) Imaging SystemMicro-Tech (Nanjing) Co., Ltd.20160—
+3K120800Nvision Vle Imaging SystemNinepoint Medical, Inc.20136—
+3K121195Nvision Vle Imaging System Nvision Vle CatheterNinepoint Medical, Inc.20120—
+4K143678NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryNinepoint Medical, Inc.201551
+5K182261NvisionVLE Imaging System, NvisionVLE Optical ProbeNinepoint Medical, Inc.20181—
+5K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K191117NvisionVLE Low-profile Optical ProbeNinepoint Medical, Inc.20190—
+6K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+7K251730LIA Console (542-7)Leadoptik, Inc.20250—