Cordia Im
by Cordis Corp.
510(k) K812540
Cordia Im is a Class II device made by Cordis Corp., cleared under FDA 510(k) K812540 on 24 Sep 1981, 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 | NumberK812540 | Date24 Sep 1981 | StatusActive |
Official records
- FDA 510(k) database K812540
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KTN
- Device class
- Class II
- Regulation
- 21 CFR Part 866.5640
- Advisory committee
- Immunology
- FDA decision
- SESE Substantially Equivalent
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