IV Administration Set
by B. Braun Medical, Inc. 2 variants
510(k) K213778
IV Administration Set is a medical device (FDA Class II; FDA product code FPA, Set, Administration, Intravascular) made by B. Braun Medical, Inc., cleared under FDA 510(k) K213778 on 3 Mar 2022, active as of 8 Nov 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 | NumberK213778 | Date3 Mar 2022 | StatusActive |
Official records
- FDA 510(k) database K213778
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FPA
- FDA applicant
- B.Braun Medical, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
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