The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for 400um Perforator And Accessory Vein Ablation Kit.
| Device ID | K181044 |
| 510k Number | K181044 |
| Device Name: | 400um Perforator And Accessory Vein Ablation Kit |
| Classification | Powered Laser Surgical Instrument |
| Applicant | AngioDynamics, Inc. 26 Forest Street Marlborough, MA 01752 |
| Contact | Deepa R. Godhiya |
| Correspondent | Deepa R. Godhiya AngioDynamics, Inc. 26 Forest Street Marlborough, MA 01752 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-19 |
| Decision Date | 2018-07-05 |
| Summary: | summary |