Submission Details
| 510(k) Number | K212386 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 02, 2021 |
| Decision Date | September 30, 2021 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
AngioVac F18 85
Sep 2021
Decision
59d
Days
Class 2
Risk
About This 510(k) Submission
K212386 is an FDA 510(k) clearance for the AngioVac F18 85, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on September 30, 2021, 59 days after receiving the submission on August 2, 2021. 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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