The following data is part of a premarket notification filed by Endophys Holdings, Llc with the FDA for Endophys Pressure Sensing Sheath Kit- 8f.
| Device ID | K173399 |
| 510k Number | K173399 |
| Device Name: | Endophys Pressure Sensing Sheath Kit- 8F |
| Classification | Introducer, Catheter |
| Applicant | Endophys Holdings, LLC 1601 Elm Street Suite 3500 Dallas, TX 75201 |
| Contact | Phillip Purdy |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-10-31 |
| Decision Date | 2017-11-30 |
| Summary: | summary |