The following data is part of a premarket notification filed by Texas Medical Technologies, Inc. with the FDA for Intranovo Microcatheter.
| Device ID | K153125 |
| 510k Number | K153125 |
| Device Name: | IntraNovo Microcatheter |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | Texas Medical Technologies, Inc. 9005 Montana Ave., Suite A El Paso, TX 79925 |
| Contact | Aaron Chiu |
| Correspondent | Ej Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-29 |
| Decision Date | 2016-01-13 |
| Summary: | summary |