The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Venacure Evlt Nevertouch Procedure Kit.
| Device ID | K171921 |
| 510k Number | K171921 |
| Device Name: | VenaCure EVLT NeverTouch Procedure Kit |
| Classification | Powered Laser Surgical Instrument |
| Applicant | AngioDynamics, Inc. 26 Forest Street Marlborough, MA 01752 |
| Contact | Hans Kjolhede |
| Correspondent | Hans Kjolhede 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 | 2017-06-27 |
| Decision Date | 2017-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787114030020 | K171921 | 000 |