Endophys Holdings, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Endophys Holdings, LLC - FDA 510(k) Cleared Devices
Recent clearances: Endophys Pressure Sensing Sheath, Endophys Pressure Sensing Sheath Kit
4
Total
4
Cleared
0
Denied
Endophys Holdings, LLC has 4 FDA 510(k) cleared medical devices. Based in Dallas, US.
Historical record: 4 cleared submissions from 2016 to 2019. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Endophys Holdings, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Sachs & Associates, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Endophys Holdings, LLC
4 devices
Cleared
Mar 07, 2019
Endophys Pressure Sensing Sheath
Cardiovascular
44d
Cleared
Oct 12, 2018
Endophys Pressure Sensing Sheath Kit
Cardiovascular
217d
Cleared
Nov 30, 2017
Endophys Pressure Sensing Sheath Kit- 8F
Cardiovascular
30d
Cleared
Sep 26, 2016
Endophys Blood Pressure Monitor
Cardiovascular
174d