Syvekexcel
by Marine Polymer Technologies, Inc.
510(k) K053300
Syvekexcel is a Class II device made by Marine Polymer Technologies, Inc., cleared under FDA 510(k) K053300 on 28 Mar 2006, 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 | NumberK053300 | Date28 Mar 2006 | StatusActive |
Official records
- FDA 510(k) database K053300
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DXC
- Device class
- Class II
- Regulation
- 21 CFR Part 870.4450
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K053300
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 | |||
|---|---|---|---|---|
| Syvek Excel Vascular Access Hemostasis Kit 400-16-05 | 400-16-05 | 00389142000155 | — | On the market |
| SyvekExcel Vascular Access Hemostasis System 400-16-05 | 400-16-05 / 400-16-05 | 00389142000056 | — | No longer on the market |
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