The following data is part of a premarket notification filed by Texas Medical Technologies, Inc. with the FDA for Intranovo 25 Microcatheter.
| Device ID | K142817 |
| 510k Number | K142817 |
| Device Name: | IntraNovo 25 Microcatheter |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | TEXAS MEDICAL TECHNOLOGIES, INC. 9005 Montana Ave., Suite A El Paso, TX 79925 |
| Contact | Aaron Chiu |
| Correspondent | Viviana I Gonzalez Pomamed Consulting LLC PO Box 9818 San Juan, PR 00908 -0818 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-29 |
| Decision Date | 2015-04-23 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() INTRANOVO 25 MICROCATHETER 86330308 5041674 Live/Registered |
SEISA TEC HOLDING S.A.R.L. 2014-07-07 |