The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Smartport Ct Vortex; Lp Titanium, Single Plastic, Single Titanium, Triumph Low Profile Titanium Ports.
| Device ID | K081472 |
| 510k Number | K081472 |
| Device Name: | SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| 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 | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-27 |
| Decision Date | 2008-09-23 |
| Summary: | summary |