The following data is part of a premarket notification filed by Endophys Holdings Llc with the FDA for Endophys Pressure Sensing Sheath.
| Device ID | K190098 |
| 510k Number | K190098 |
| Device Name: | Endophys Pressure Sensing Sheath |
| Classification | Introducer, Catheter |
| Applicant | Endophys Holdings LLC 1601 Elm Street, Suite 1965 Dallas, TX 75201 |
| Contact | Phillip Purdy |
| Correspondent | Gregory W. Sachs Sachs & Associates, Inc 5116 Birch Road Minnetonka, MN 55345 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-22 |
| Decision Date | 2019-03-07 |