The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Transjugular Access Set.
| Device ID | K964034 |
| 510k Number | K964034 |
| Device Name: | TRANSJUGULAR ACCESS SET |
| Classification | Introducer, Catheter |
| Applicant | ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Contact | Brian Kunst |
| Correspondent | Brian Kunst ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-08 |
| Decision Date | 1997-05-06 |