UNI*FUSE Infusion System with Cooper Wire
FDA 510(k) clearance K192864 · decided 2020-06-01
Clearance details
- K-number
- K192864
- Device name
- UNI*FUSE Infusion System with Cooper Wire
- Applicant
- AngioDynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-10-07
- Decision date
- 2020-06-01
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- QEY
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.