Pantheris System
510(k) K212047
Pantheris System is a Class II device made by Avinger, Inc., cleared under FDA 510(k) K212047 on 16 Nov 2021, active as of 10 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 | NumberK212047 | Date16 Nov 2021 | StatusActive |
Official records
- FDA 510(k) database K212047
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MCW
- Device class
- Class II
- Regulation
- 21 CFR Part 870.4875
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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