Tacvac
by Athena Gtx
510(k) K153459
Tacvac is a medical device (FDA Class II; FDA product code BTA, Pump, Portable, Aspiration (Manual Or Powered)) made by Athena Gtx, cleared under FDA 510(k) K153459 on 28 Jan 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK153459 | Date28 Jan 2016 | StatusActive |
Official records
- FDA 510(k) database K153459
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BTA
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4780
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K153459
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| TACVAC Collection Unit | 510-0006-01 / Collection Unit | B3945100006010 | No longer on the market | |
| TACVAC Suction Unit | 530-0021-01 / Suction Unit | B3945300021010 | No longer on the market |
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