The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Venacure Evlt Nevertouch Procedure Kit, Venacure Evlt Tre' Sheath.
| Device ID | K133561 |
| 510k Number | K133561 |
| Device Name: | VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Contact | Lorraine M Hanley |
| Correspondent | Lorraine M Hanley ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. 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 | 2013-11-20 |
| Decision Date | 2013-12-19 |
| Summary: | summary |