CorPath 200 System
510(k) K152999
CorPath 200 System is a Class II device made by Corindus, Inc., cleared under FDA 510(k) K152999 on 18 Mar 2016, active as of 11 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 | NumberK152999 | Date18 Mar 2016 | StatusActive |
Official records
- FDA 510(k) database K152999
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DXX
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1290
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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