Delta Fly® 3681622
Delta Fly® 3681622 is a Class II device made by Delta Med SpA, cleared under FDA 510(k) K140175 on 5 Aug 2014 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 08032248368163), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08032248368163 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140175 | Date5 Aug 2014 | StatusActive |
Official records
- AccessGUDID record 08032248368163
- FDA 510(k) database K140175
Across registries
- FDA 510(k) K140175 decided 5 Aug 2014 Active
- FDA GUDID UDI-DI 08032248368163 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K140175
- Listed FDA GUDID 08032248368163
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Delta Fly®
- Generic name
- Venous butterfly needle/set
- Model / reference
- 3681622
- Primary DI / UDI-DI
- 08032248368163
- 510(k) Number
- FDA product code
- FPA
- GMDN term
- Venous butterfly needle/set
- Device class
- Class II
- Regulation number
- 880.5440
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 0.6 MillimeterLength — 20 MillimeterNeedle Gauge — 23 Gauge
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