UNIFUSE Infusion System with Cooper Wire
FDA 510(k) K202347 · AngioDynamics, Inc.
510(k) numberK202347
Submission
- Device name
- UNIFUSE Infusion System with Cooper Wire
- Applicant
- AngioDynamics, Inc.
Marlborough, MA, US - Received
- August 18, 2020
- Decision date
- September 15, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEY – Mechanical Thrombolysis Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
To mechanically disrupt thrombus and/or debris in the peripheral vasculature.
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Questions and answers
When was UNIFUSE Infusion System with Cooper Wire cleared by the FDA?
UNIFUSE Infusion System with Cooper Wire (K202347) received a 510(k) decision of Substantially Equivalent on September 15, 2020, 28 days after the submission was received.
What is the product code of K202347?
The FDA product code is QEY – Mechanical Thrombolysis Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.