UniFuse H787124018260
UniFuse H787124018260 is a Class II device made by Angiodynamics, Inc., cleared under FDA 510(k) K163356 on 30 May 2017 and listed in FDA GUDID since 6 Sep 2024 (UDI-DI 15051684013987), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number15051684013987 | Date6 Sep 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163356 | Date30 May 2017 | StatusActive |
Official records
- AccessGUDID record 15051684013987
- FDA 510(k) database K163356
Across registries
- FDA 510(k) K163356 decided 30 May 2017 Active
- FDA GUDID UDI-DI 15051684013987 listed 6 Sep 2024 Listed
Recalls
-
- Ongoing Z-1010-2024
Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
Timeline
- Cleared FDA 510(k) K163356
- Recall initiated FDA recalls Z-1010-2024
- Listed FDA GUDID 15051684013987
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- UniFuse
- Generic name
- Peripheral vascular intervention infusion catheter
- Model / Ref / Catalog
- H787124018260, 12401826
- Primary DI / UDI-DI
- 15051684013987
- 510(k) Number
- FDA product code
- KRA
- GMDN term
- Peripheral vascular intervention infusion catheter
- Device class
- Class II
- Regulation number
- 870.1210
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 1.43 MillimeterCatheter Gauge — 4 FrenchLength — 45 Centimeter
Similar devices in this category
Other devices filed under Peripheral vascular intervention infusion catheter.