The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Venacure Evlt Nevertouch Direct Introducer Sheath.
| Device ID | K170695 |
| 510k Number | K170695 |
| Device Name: | VenaCure EVLT NeverTouch Direct Introducer Sheath |
| Classification | Introducer, Catheter |
| Applicant | AngioDynamics, Inc. 26 Forest Street Marlborough,, MA 01752 |
| Contact | Robin Fuller |
| Correspondent | Robin Fuller AngioDynamics, Inc. 26 Forest Street Marlborough,, MA 01752 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-07 |
| Decision Date | 2017-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787165100010 | K170695 | 000 |