The following data is part of a premarket notification filed by Endophys, Inc. with the FDA for Endophys Pressure Sensing Sheath Kit.
| Device ID | K160272 |
| 510k Number | K160272 |
| Device Name: | Endophys Pressure Sensing Sheath Kit |
| Classification | Introducer, Catheter |
| Applicant | Endophys, Inc. Thanksgiving Tower, Suite 1930 1601 Elm Street Dallas, TX 75201 |
| Contact | Rebecca K Pine |
| Correspondent | Rebecca K Pine Endophys, Inc. Thanksgiving Tower, Suite 1930 1601 Elm Street Dallas, TX 75201 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-02 |
| Decision Date | 2016-03-04 |
| Summary: | summary |