TACVAC
Pump, Portable, Aspiration (manual Or Powered)
ATHENA GTX
The following data is part of a premarket notification filed by Athena Gtx with the FDA for Tacvac.
Pre-market Notification Details
| Device ID | K153459 |
| 510k Number | K153459 |
| Device Name: | TACVAC |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | ATHENA GTX 5900 NW 86TH STREET, SUITE 300 Johnston, IA 50131 |
| Contact | Sean Mahoney |
| Correspondent | Sean Mahoney ATHENA GTX 5900 NW 86TH STREET, SUITE 300 Johnston, IA 50131 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-01 |
| Decision Date | 2016-01-28 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3945300021010 | K153459 | 000 |
| B3945100006010 | K153459 | 000 |
Trademark Results [TACVAC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TACVAC 86795941 5205632 Live/Registered |
Athena GTX, Inc. 2015-10-22 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.