The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiovac F18 85.
| Device ID | K212386 |
| 510k Number | K212386 |
| Device Name: | AngioVac F18 85 |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | AngioDynamics, Inc. 603 Queensbury Ave Queensbury, NY 12804 |
| Contact | Kasey E. Newcomb |
| Correspondent | Kasey E. Newcomb AngioDynamics, Inc. 603 Queensbury Ave Queensbury, NY 12804 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-02 |
| Decision Date | 2021-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15051684025973 | K212386 | 000 |
| H965252000 | K212386 | 000 |