Baim Coronary Sinus Flow Calculator
510(k) K842831
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842831 | Date27 Aug 1984 | StatusActive |
Recalls
No FDA recalls found in the data synced 9 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXG
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1435
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent