Implanted ports
Vortex
A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.
Vortex models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| LVTX5013 | Length 76 cm; Needle Gauge 18 G; Outer Diameter 3.2 mm; Lumen/Inner Diameter 1.5 mm; Catheter Gauge 9.6 Fr | MR Conditional | Available |
| LVTX5015 | Length 76 cm; Catheter Gauge 9.6 Fr; Needle Gauge 18 G; Outer Diameter 3.2 mm; Lumen/Inner Diameter 1.5 mm | MR Conditional | Available |
| LVTX5213 | Needle Gauge 18 G; Lumen/Inner Diameter 1.3 mm; Length 76 cm; Catheter Gauge 11.4 Fr; Outer Diameter 3.8 mm | MR Conditional | Available |
| LVTX5513 | Needle Gauge 18 G; Length 76 cm; Catheter Gauge 8.4 Fr; Lumen/Inner Diameter 1.6 mm; Outer Diameter 2.8 mm | MR Conditional | Available |
| LVTX7013 | Length 76 cm; Needle Gauge 18 G; Outer Diameter 3.2 mm; Lumen/Inner Diameter 1.5 mm; Catheter Gauge 9.6 Fr | MR Conditional | Available |
| LVTX7015 | Needle Gauge 18 G; Lumen/Inner Diameter 1.5 mm; Catheter Gauge 9.6 Fr; Outer Diameter 3.2 mm; Length 76 cm | MR Conditional | Available |
| LVTX7513 | Needle Gauge 18 G; Lumen/Inner Diameter 1.6 mm; Catheter Gauge 8.4 Fr; Outer Diameter 2.8 mm; Length 76 cm | MR Conditional | Available |
| MP-P5PK | Lumen/Inner Diameter 1 mm; Needle Gauge 18 G; Outer Diameter 1.7 mm; Catheter Gauge 5 Fr; Length 76 cm | MR Conditional | Available |
| MP-P5PT | Needle Gauge 18 G; Lumen/Inner Diameter 1 mm; Outer Diameter 1.7 mm; Catheter Gauge 5 Fr; Length 76 cm | MR Conditional | Available |
| MP-P5SAT | Length 76 cm; Needle Gauge 18 G; Catheter Gauge 5 Fr; Outer Diameter 1.7 mm; Lumen/Inner Diameter 0.9 mm | MR Conditional | Available |
| MP-P5SDT | Length 76 cm; Needle Gauge 18 G; Lumen/Inner Diameter 0.9 mm; Catheter Gauge 5 Fr; Outer Diameter 1.7 mm | MR Conditional | Available |
| P5305K | Needle Gauge 18 G; Lumen/Inner Diameter 1.3 mm; Length 53 cm; Catheter Gauge 7.2 Fr; Outer Diameter 2.4 mm | MR Conditional | Available |
| P5355K | Needle Gauge 18 G; Outer Diameter 2.4 mm; Length 53 cm; Catheter Gauge 7.2 Fr; Lumen/Inner Diameter 1.3 mm | MR Conditional | Available |
| P5405K | Catheter Gauge 9.6 Fr; Outer Diameter 3.2 mm; Needle Gauge 18 G; Lumen/Inner Diameter 1.6 mm; Length 53 cm | MR Conditional | Available |
| P5455K | Needle Gauge 18 G; Length 53 cm; Lumen/Inner Diameter 1.6 mm; Outer Diameter 3.2 mm; Catheter Gauge 9.6 Fr | MR Conditional | Available |
| PSAX-10-I | Needle Gauge 18 G; Length 76 cm; Lumen/Inner Diameter 1 mm; Outer Diameter 2.2 mm; Catheter Gauge 6.6 Fr | MR Conditional | Available |
| PSDX-10-I | Needle Gauge 18 G; Length 76 cm; Lumen/Inner Diameter 1 mm; Outer Diameter 2.2 mm; Catheter Gauge 6.6 Fr | MR Conditional | Available |
| SPAX-16-I | Needle Gauge 18 G; Length 53 cm; Catheter Gauge 9.6 Fr; Lumen/Inner Diameter 1.6 mm; Outer Diameter 3.2 mm | MR Conditional | Available |
| SPDX-14-I | Needle Gauge 18 G; Catheter Gauge 7.5 Fr; Length 70 cm; Lumen/Inner Diameter 1.4 mm; Outer Diameter 2.5 mm | MR Conditional | Available |
| SPDX-16-I | Needle Gauge 18 G; Outer Diameter 3.2 mm; Catheter Gauge 9.6 Fr; Lumen/Inner Diameter 1.6 mm; Length 70 cm | MR Conditional | Available |
| SSAX-14-I | Needle Gauge 18 G; Outer Diameter 2.5 mm; Lumen/Inner Diameter 1.4 mm; Length 70 cm; Catheter Gauge 7.5 Fr | MR Conditional | Available |
| SSAX-16-I | Lumen/Inner Diameter 1.6 mm; Length 53 cm; Needle Gauge 18 G; Outer Diameter 3.2 mm; Catheter Gauge 9.6 Fr | MR Conditional | Available |
| SSDX-10-I | Needle Gauge 18 G; Length 70 cm; Catheter Gauge 6.6 Fr; Lumen/Inner Diameter 1 mm; Outer Diameter 2.2 mm | MR Conditional | Available |
| SSDX-14-I | Needle Gauge 18 G; Catheter Gauge 7.5 Fr; Length 70 cm; Lumen/Inner Diameter 1.4 mm; Outer Diameter 2.5 mm | MR Conditional | Available |
| SSDX-16-I | Length 70 cm; Needle Gauge 18 G; Catheter Gauge 9.6 Fr; Outer Diameter 3.2 mm; Lumen/Inner Diameter 1.6 mm | MR Conditional | Available |
FDA clearances
- 510(k) K033473 November 2003
- 510(k) K032557 September 2003
- 510(k) K010767 April 2001
- 510(k) K010189 February 2001
- 510(k) K951814 August 1995
Procedures that use implanted ports
Frequently asked questions
What is Vortex used for?
A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.
Who makes Vortex?
Vortex is made by Navilyst Medical, Inc.. It is listed under implanted ports (port-a-cath) in our device library.
What sizes does Vortex come in?
Sizes listed for Vortex: Length: 53–76 cm; Needle Gauge: 18 G; Outer Diameter: 1.7–3.8 mm. Confirm availability with the manufacturer's instructions for use.
Is Vortex MRI safe?
The FDA device database lists Vortex as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Vortex FDA cleared?
Vortex is covered by FDA submissions K010767, K951814, K010189, K033473, K032557.
How do I contact a Navilyst Medical, Inc. sales representative?
Navilyst Medical, Inc. has not listed representatives on LA Vascular yet. Visit the Navilyst Medical, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.