OptiMap™ System
510(k) K251344
OptiMap™ System is a Class II device made by Boston Scientific, cleared under FDA 510(k) K251344 on 28 May 2025, active as of 25 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 | NumberK251344 | Date28 May 2025 | StatusActive |
Official records
- FDA 510(k) database K251344
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DQK
- FDA applicant
- Boston Scientific Corporation
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1425
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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