510(k) K192864
K192864 is an FDA 510(k) premarket notification submitted by AngioDynamics, Inc. for the device "UNI*FUSE Infusion System with Cooper Wire". The FDA issued a decision of Substantially Equivalent on June 1, 2020. The device falls under product code QEY (Mechanical Thrombolysis Catheter), a Class II device regulated under 21 CFR 870.5150. AngioDynamics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 2020
- Date Received
- October 7, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mechanical Thrombolysis Catheter
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type
To mechanically disrupt thrombus and/or debris in the peripheral vasculature.