The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiovac C20, Angiovac C180.
| Device ID | K190594 |
| 510k Number | K190594 |
| Device Name: | AngioVac C20, AngioVac C180 |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | AngioDynamics, Inc. 26 Forest St. Marlborough, MA 01752 |
| Contact | Kasey Newcomb |
| Correspondent | Kasey Newcomb AngioDynamics, Inc. 26 Forest St. Marlborough, MA 01752 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-07 |
| Decision Date | 2019-07-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H965251940 | K190594 | 000 |
| H965251930 | K190594 | 000 |