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 |