V10
510(k) K152659
V10 is a Class II device made by Mediana.CO.LTD, cleared under FDA 510(k) K152659 on 25 Aug 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 | NumberK152659 | Date25 Aug 2016 | StatusActive |
Official records
- FDA 510(k) database K152659
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DXN
- FDA applicant
- Mediana Co., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K152659
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 | |||
|---|---|---|---|---|
| Direct Supply AVSM2 | V10D-3PBNRU / AVSM2 | 18800003447487 | — | On the market |
| Direct Supply AVSM2 | V10D-3PXCRU / AVSM2 | 18800003424990 | — | No longer on the market |
| Direct Supply AVSM2 | V10D-3PXNRU / AVSM2 | 18800003424952 | — | On the market |
| Direct Supply AVSM2 | V10D-3XBNRU / AVSM2 | 18800003447470 | — | On the market |
| Direct Supply AVSM2 | V10D-3XBNZU / AVSM2 | 18800003447494 | — | On the market |
| Direct Supply AVSM2 | V10D-3XXCRU / AVSM2 | 18800003424792 | — | No longer on the market |
| Direct Supply AVSM2 | V10D-3XXCZU / AVSM2 | 18800003424808 | — | No longer on the market |
| Direct Supply AVSM2 | V10D-3XXNRU / AVSM2 | 18800003424754 | — | On the market |
| Direct Supply AVSM2 | V10D-3XXNZU / AVSM2 | 18800003424761 | — | On the market |
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