The following data is part of a premarket notification filed by Texas Medical Technologies, Inc. with the FDA for Txm Hydrophilic Guidewire.
| Device ID | K170915 |
| 510k Number | K170915 |
| Device Name: | TXM Hydrophilic Guidewire |
| Classification | Wire, Guide, Catheter |
| Applicant | Texas Medical Technologies, Inc. 9005 Montana Ave., Suite. A El Paso, TX 79925 |
| Contact | Aaron Chiu |
| Correspondent | E. J. Smith Smith Associates Crofton, MD 21114 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-28 |
| Decision Date | 2017-11-21 |
| Summary: | summary |