K202347 is an FDA 510(k) clearance for the UNIFUSE Infusion System with Cooper Wire. This device is classified as a Mechanical Thrombolysis Catheter (Class II - Special Controls, product code QEY).
Submitted by AngioDynamics, Inc. (Marlborough, US). The FDA issued a Cleared decision on September 15, 2020, 28 days after receiving the submission on August 18, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150. To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature..
| 510(k) Number | K202347 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2020 |
| Decision Date | September 15, 2020 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| 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. |