Vortex
Vortex VX Single Titanium Port System with Attachable 9.6F x 53cm Silicone Catheter and Tray
2manufacturers in China registered for this device type
25catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
Record
| Listed by | Navilyst Medical, Inc., United States |
|---|---|
| FDA product code | LJT |
| Device type | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5965 |
| 510(k) | K032557 |
| Record published | 2018-02-07 |
| Record revised | 2020-07-27 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Needle gauge 18 G; length 53 to 76 cm; lumen/inner diameter 0.9 to 1.6 mm; outer diameter 1.7 to 3.8 mm; catheter gauge 5 to 11.4 Fr |
| Distribution end date | 2021-11-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PSDX-10-I | Needle Gauge 18 G | In distribution |
| LVTX5213 | Needle Gauge 18 G | In distribution |
| SPAX-16-I | Needle Gauge 18 G | In distribution |
| SSDX-10-I | Needle Gauge 18 G | In distribution |
| LVTX5013 | Length 76 cm | In distribution |
| MP-P5PK | Lumen/Inner Diameter 1 mm | In distribution |
| P5455K | Needle Gauge 18 G | In distribution |
| SSDX-14-I | Needle Gauge 18 G | In distribution |
| MP-P5PT | Needle Gauge 18 G | In distribution |
| P5405K | Catheter Gauge 9.6 Fr | In distribution |
| LVTX7013 | Length 76 cm | In distribution |
| SPDX-16-I | Needle Gauge 18 G | In distribution |
| MP-P5SDT | Length 76 cm | In distribution |
| SSAX-16-I | Lumen/Inner Diameter 1.6 mm | In distribution |
| LVTX7015 | Needle Gauge 18 G | In distribution |
| PSAX-10-I | Needle Gauge 18 G | In distribution |
| MP-P5SAT | Length 76 cm | In distribution |
| SSDX-16-I | Length 70 cm | In distribution |
| SSAX-14-I | Needle Gauge 18 G | In distribution |
| P5355K | Needle Gauge 18 G | In distribution |
| LVTX5015 | Length 76 cm | In distribution |
| SPDX-14-I | Needle Gauge 18 G | In distribution |
| P5305K | Needle Gauge 18 G | In distribution |
| LVTX7513 | Needle Gauge 18 G | Withdrawn |
| LVTX5513 | Needle Gauge 18 G | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dignity® | Medical Components Inc | 168 |
| Deltec | ICU Medical, Inc | 130 |
| NorPort Vascular Access Port | Norfolk Medical | 106 |
| BioFlo Vortex | AngioDynamics, Inc. | 60 |
| BioFlo Vortex | Navilyst Medical, Inc. | 59 |
| Dignity® MID-Sized CT Port | Medical Components Inc | 55 |
| TidalPort Vascular Access Port | Norfolk Medical | 52 |
| Pro-Fuse® Low Profile CT Port | Medical Components Inc | 45 |
| Dignity® Low Profile CT Port | Medical Components Inc | 45 |
| Dignity® Mini CT Port | Medical Components Inc | 44 |
| Medcomp GEN III Power Injectable Portmedcomp GEN III Power Injectable Port | Medical Components Inc | 29 |
| PRO-Fuse® | Medical Components Inc | 28 |
Showing 12 of 96. All products under Port & Catheter, Implanted, Subcutaneous, Intravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151239 | 2016-06-06 |
| K153228 | 2015-12-04 |
| K131694 | 2013-08-08 |
| K122767 | 2013-04-30 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| AngioDynamics, Inc. | 510(k) number | 2022-09-20 | Class II | Under Investigation by firm | Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, fa | 11 units | |
| AngioDynamics, Inc. | 510(k) number | 2010-08-30 | Not classified | Labeling False and Misleading | The labeling contains errors which result in the products being misbranded | 69 units | 2012-03-12 |
| AngioDynamics, Inc. | 510(k) number | 2007-10-03 | Not classified | Employee error | Incorrect Size Catheter: The product may contain an incorrect size catheter. | 150 kits | 2008-07-14 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.