Submission Details
| 510(k) Number | K253106 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 24, 2025 |
| Decision Date | October 24, 2025 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
AngioVac Cannula
Oct 2025
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K253106 is an FDA 510(k) clearance for the AngioVac Cannula, 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 October 24, 2025, 30 days after receiving the submission on September 24, 2025. 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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