UNI*FUSE Infusion System with Cooper Wire— 510(k) K192864
Substantially EquivalentAngioDynamics, Inc.
FDA 510(k) clearance K192864 for UNI*FUSE Infusion System with Cooper Wire, Substantially Equivalent on 2020-06-01. Applicant: AngioDynamics, Inc.. Device class: 2.
Clearance details
- Applicant
- AngioDynamics, Inc.
- Product code
- Code QEY
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
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