Reconstitution Device
510(k) K910793
Reconstitution Device is a medical device (FDA Class II; FDA product code LHI, Set, I.V. Fluid Transfer) made by Baxter Healthcare Corp, cleared under FDA 510(k) K910793 on 21 Mar 1991, 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 | NumberK910793 | Date21 Mar 1991 | StatusActive |
Official records
- FDA 510(k) database K910793
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LHI
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
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