The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiovac Cannula.
| Device ID | K142593 |
| 510k Number | K142593 |
| Device Name: | AngioVac Cannula |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | AngioDynamics, Inc. 26 Forest Street Marlborough, MA 01752 |
| Contact | Wanda Carpinella |
| Correspondent | Wanda Carpinella AngioDynamics, Inc. 26 Forest Street 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 | 2014-09-15 |
| Decision Date | 2014-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H965251860 | K142593 | 000 |
| H965251850 | K142593 | 000 |