The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiodynamics Venacure Evlt Tre’ Sheath And Venacure Evlt Nevertouch Procedure Kits.
| Device ID | K142614 |
| 510k Number | K142614 |
| Device Name: | AngioDynamics VenaCure EVLT Tre’ Sheath And VenaCure EVLT NeverTouch Procedure Kits |
| Classification | Powered Laser Surgical Instrument |
| Applicant | AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, NY 12804 |
| Contact | Teri Juckett |
| Correspondent | Teri Juckett AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, NY 12804 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-16 |
| Decision Date | 2014-10-10 |
| Summary: | summary |