Submission Details
| 510(k) Number | K192864 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 07, 2019 |
| Decision Date | June 01, 2020 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
UNI*FUSE Infusion System with Cooper Wire
Jun 2020
Decision
238d
Days
Class 2
Risk
About This 510(k) Submission
K192864 is an FDA 510(k) clearance for the UNI*FUSE Infusion System with Cooper Wire, a Mechanical Thrombolysis Catheter (Class II — Special Controls, product code QEY), submitted by AngioDynamics, Inc. (Marlborough, US). The FDA issued a Cleared decision on June 1, 2020, 238 days after receiving the submission on October 7, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.
Device Classification
| Product Code | QEY — Mechanical Thrombolysis Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.5150 |
| Definition | To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature. |
Manufacturer
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