Submission Details
| 510(k) Number | K190594 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 07, 2019 |
| Decision Date | July 05, 2019 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
AngioVac C20, AngioVac C180
Jul 2019
Decision
120d
Days
Class 2
Risk
About This 510(k) Submission
K190594 is an FDA 510(k) clearance for the AngioVac C20, AngioVac C180, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by AngioDynamics, Inc. (Marlborough, US). The FDA issued a Cleared decision on July 5, 2019, 120 days after receiving the submission on March 7, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.
Device Classification
| Product Code | DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4210 |
Manufacturer
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