Implanted ports
BioFlo 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.
Where to buy BioFlo Vortex
We do not have contact details for Navilyst Medical, Inc. yet. Send a request and we will route it to the right person for your country.
BioFlo 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 |
|---|---|---|---|
| CT50LPBANFVI | Catheter Gauge 5 Fr; Outer Diameter 1.8 mm; Length 45 cm | MR Conditional | Available |
| CT50LPBAVI | Length 45 cm; Catheter Gauge 5 Fr; Outer Diameter 1.8 mm | MR Conditional | Available |
| CT50LPBDNFVI | Outer Diameter 1.8 mm; Length 45 cm; Catheter Gauge 5 Fr | MR Conditional | Available |
| CT50LPBDVI | Outer Diameter 1.8 mm; Length 63 cm; Catheter Gauge 5 Fr | MR Conditional | Available |
| CT50LTBANFVI | Outer Diameter 1.8 mm; Length 45 cm; Catheter Gauge 5 Fr | MR Conditional | Available |
| CT50LTBAVI | Outer Diameter 1.8 mm; Catheter Gauge 5 Fr; Length 45 cm | MR Conditional | Available |
| CT50LTBDNFVI | Length 45 cm; Catheter Gauge 5 Fr; Outer Diameter 1.8 mm | MR Conditional | Available |
| CT50LTBDVI | Outer Diameter 1.8 mm; Length 45 cm; Catheter Gauge 5 Fr | MR Conditional | Available |
| CT50PTBANFVI | Catheter Gauge 5 Fr; Outer Diameter 1.8 mm; Length 45 cm | MR Conditional | Available |
| CT50PTBAVI | Catheter Gauge 5 Fr; Length 45 cm; Outer Diameter 1.8 mm | MR Conditional | Available |
| CT50PTBDNFVI | Outer Diameter 1.8 mm; Catheter Gauge 5 Fr; Length 45 cm | MR Conditional | Available |
| CT50PTBDVI | Length 45 cm; Catheter Gauge 5 Fr; Outer Diameter 1.8 mm | MR Conditional | Available |
| CT50STBAVI | Length 45 cm; Catheter Gauge 5 Fr; Outer Diameter 1.8 mm | MR Conditional | Available |
| CT50STBDNFVI | Length 45 cm; Outer Diameter 1.8 mm; Catheter Gauge 5 Fr | MR Conditional | Available |
| CT50STBDVI | Outer Diameter 1.8 mm; Length 45 cm; Catheter Gauge 5 Fr | MR Conditional | Available |
| CT60LPBANFVI | Length 63 cm; Outer Diameter 2.1 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| CT60LPBAVI | Catheter Gauge 6 Fr; Length 63 cm; Outer Diameter 2.1 mm | MR Conditional | Available |
| CT60LPBDNFVI | Outer Diameter 2.1 mm; Catheter Gauge 6 Fr; Length 63 cm | MR Conditional | Available |
| CT60LPBDVI | Catheter Gauge 6 Fr; Outer Diameter 2.1 mm; Length 63 cm | MR Conditional | Available |
| CT60LPPANFNV | Catheter Gauge 6 Fr; Length 63 cm; Outer Diameter 2.1 mm | MR Conditional | Available |
| CT60LPPANFVI | Catheter Gauge 6 Fr; Length 63 cm; Outer Diameter 2.1 mm | MR Conditional | Available |
| CT60LPPANV | Outer Diameter 2.1 mm; Catheter Gauge 6 Fr; Length 63 cm | MR Conditional | Available |
| CT60LPPAVI | Catheter Gauge 6 Fr; Length 63 cm; Outer Diameter 2.1 mm | MR Conditional | Available |
| CT60LPPDNFNV | Length 63 cm; Outer Diameter 2.1 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| CT60LPPDNFVI | Outer Diameter 2.1 mm; Length 63 cm; Catheter Gauge 6 Fr | MR Conditional | Available |
| CT60LPPDNV | Length 63 cm; Outer Diameter 2.1 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| CT60LPPDVI | Length 63 cm; Catheter Gauge 6 Fr; Outer Diameter 2.1 mm | MR Conditional | Available |
| CT60LTBANFVI | Outer Diameter 2.1 mm; Length 63 cm; Catheter Gauge 6 Fr | MR Conditional | Available |
| CT60LTBAVI | Outer Diameter 2.1 mm; Catheter Gauge 6 Fr; Length 63 cm | MR Conditional | Available |
| CT60LTBDNFVI | Outer Diameter 2.1 mm; Length 63 cm; Catheter Gauge 6 Fr | MR Conditional | Available |
| CT60LTBDVI | Length 63 cm; Outer Diameter 2.1 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| CT60PTBANFVI | Outer Diameter 2.1 mm; Catheter Gauge 6 Fr; Length 63 cm | MR Conditional | Available |
| CT60PTBAVI | Catheter Gauge 6 Fr; Length 63 cm; Outer Diameter 2.1 mm | MR Conditional | Available |
| CT60PTBDNFVI | Length 63 cm; Outer Diameter 2.1 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| CT60PTBDVI | Length 63 cm; Outer Diameter 2.1 mm; Catheter Gauge 6 Fr | MR Conditional | Available |
| CT60STBANFVI | Catheter Gauge 6 Fr; Outer Diameter 2.1 mm; Length 63 cm | MR Conditional | Available |
| CT60STBAVI | Length 63 cm; Catheter Gauge 6 Fr; Outer Diameter 2.1 mm | MR Conditional | Available |
| CT60STBDNFVI | Outer Diameter 2.1 mm; Length 63 cm; Catheter Gauge 6 Fr | MR Conditional | Available |
| CT60STBDVI | Outer Diameter 2.1 mm; Catheter Gauge 6 Fr; Length 63 cm | MR Conditional | Available |
| CT80LPBANFVI | Catheter Gauge 8 Fr; Length 63 cm; Outer Diameter 2.6 mm | MR Conditional | Available |
| CT80LPBAVI | Catheter Gauge 8 Fr; Outer Diameter 2.6 mm; Length 63 cm | MR Conditional | Available |
| CT80LPBDNFVI | Outer Diameter 2.67 mm; Catheter Gauge 8 Fr; Length 63 cm | MR Conditional | Available |
| CT80LPBDVI | Length 63 cm; Catheter Gauge 8 Fr; Outer Diameter 2.67 mm | MR Conditional | Available |
| CT80LPPANFNV | Length 63 cm; Outer Diameter 2.6 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| CT80LPPANFVI | Length 63 cm; Catheter Gauge 8 Fr; Outer Diameter 2.6 mm | MR Conditional | Available |
| CT80LPPANV | Outer Diameter 2.6 mm; Length 63 cm; Catheter Gauge 8 Fr | MR Conditional | Available |
| CT80LPPAVI | Length 63 cm; Catheter Gauge 8 Fr; Outer Diameter 2.6 mm | MR Conditional | Available |
| CT80LPPDNFNV | Outer Diameter 2.6 mm; Catheter Gauge 8 Fr; Length 63 cm | MR Conditional | Available |
| CT80LPPDNFVI | Length 63 cm; Outer Diameter 2.67 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| CT80LPPDNV | Catheter Gauge 8 Fr; Outer Diameter 2.67 mm; Length 63 cm | MR Conditional | Available |
| CT80LPPDVI | Length 63 cm; Catheter Gauge 8 Fr; Outer Diameter 2.67 mm | MR Conditional | Available |
| CT80LTBANFVI | Catheter Gauge 8 Fr; Length 63 cm; Outer Diameter 2.6 mm | MR Conditional | Available |
| CT80LTBAVI | Catheter Gauge 8 Fr; Outer Diameter 2.6 mm; Length 63 cm | MR Conditional | Available |
| CT80LTBDNFVI | Outer Diameter 2.6 mm; Length 63 cm; Catheter Gauge 8 Fr | MR Conditional | Available |
| CT80LTBDVI | Catheter Gauge 8 Fr; Length 63 cm; Outer Diameter 2.67 mm | MR Conditional | Available |
| CT80STBANFVI | Catheter Gauge 8 Fr; Length 63 cm; Outer Diameter 2.6 mm | MR Conditional | Available |
| CT80STBAVI | Outer Diameter 2.6 mm; Catheter Gauge 8 Fr; Length 63 cm | MR Conditional | Available |
| CT80STBDNFVI | Catheter Gauge 8 Fr; Outer Diameter 2.6 mm; Length 63 cm | MR Conditional | Available |
| CT80STBDVI | Outer Diameter 2.67 mm; Length 63 cm; Catheter Gauge 8 Fr | MR Conditional | Available |
FDA clearances
- 510(k) K190559 May 2020
Procedures that use implanted ports
Frequently asked questions
What is BioFlo 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 BioFlo Vortex?
BioFlo Vortex is made by Navilyst Medical, Inc.. It is listed under implanted ports (port-a-cath) in our device library.
What sizes does BioFlo Vortex come in?
Sizes listed for BioFlo Vortex: Length: 45–63 cm; Outer Diameter: 1.8–2.67 mm; Catheter Gauge: 5–8 Fr. Confirm availability with the manufacturer's instructions for use.
Is BioFlo Vortex MRI safe?
The FDA device database lists BioFlo Vortex as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is BioFlo Vortex FDA cleared?
BioFlo Vortex is covered by FDA submission K190559.
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.