Implanted ports
BioFlo
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
We do not have contact details for AngioDynamics, Inc. yet. Send a request and we will route it to the right person for your country.
BioFlo 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 |
|---|---|---|---|
| H965440110 | Lumen/Inner Diameter 1.3 mm; Catheter Gauge 6 Fr; Outer Diameter 2.1 mm; Length 63 cm | MR Conditional | Available |
| H965440120 | Outer Diameter 2.1 mm; Lumen/Inner Diameter 1.3 mm; Length 63 cm; Catheter Gauge 6 Fr | MR Conditional | Available |
| H965440130 | Length 63 cm; Catheter Gauge 8 Fr; Lumen/Inner Diameter 1.6 mm; Outer Diameter 2.6 mm | MR Conditional | Available |
| H965440140 | Lumen/Inner Diameter 1.6 mm; Length 63 cm; Outer Diameter 2.6 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| H965440150 | Catheter Gauge 6 Fr; Lumen/Inner Diameter 1.3 mm; Length 63 cm; Outer Diameter 2.1 mm | MR Conditional | Available |
| H965440170 | Catheter Gauge 8 Fr; Lumen/Inner Diameter 1.6 mm; Length 63 cm; Outer Diameter 2.6 mm | MR Conditional | Available |
| H965440190 | Catheter Gauge 6 Fr; Outer Diameter 2.1 mm; Lumen/Inner Diameter 1.3 mm; Length 63 cm | MR Conditional | Available |
| H965440200 | Outer Diameter 2.1 mm; Lumen/Inner Diameter 1.3 mm; Length 63 cm; Catheter Gauge 6 Fr | MR Conditional | Available |
| H965440210 | Length 63 cm; Catheter Gauge 8 Fr; Lumen/Inner Diameter 1.6 mm; Outer Diameter 2.6 mm | MR Conditional | Available |
| H965440220 | Length 63 cm; Catheter Gauge 8 Fr; Lumen/Inner Diameter 1.6 mm; Outer Diameter 2.6 mm | MR Conditional | Available |
| H965440230 | Lumen/Inner Diameter 1.3 mm; Length 63 cm; Catheter Gauge 6 Fr; Outer Diameter 2.1 mm | MR Conditional | Available |
| H965440250 | Lumen/Inner Diameter 1.6 mm; Length 63 cm; Outer Diameter 2.6 mm; Catheter Gauge 8 Fr | MR Conditional | Available |
| H965440270 | Length 63 cm; Catheter Gauge 8 Fr; Outer Diameter 2.6 mm | MR Conditional | Available |
| H965440280 | Outer Diameter 2.6 mm; Length 63 cm; Catheter Gauge 8 Fr | MR Conditional | Available |
| H965460320 | Outer Diameter 1.02 mm; Lumen/Inner Diameter 0.018 in; Length 10 cm; Catheter Gauge 3 Fr | Not stated | Available |
| H965460330 | Catheter Gauge 3 Fr; Length 10 cm; Outer Diameter 1.02 mm; Lumen/Inner Diameter 0.018 in | Not stated | Available |
| H965460420 | Lumen/Inner Diameter 0.018 in; Outer Diameter 1.4 mm; Length 10 cm; Catheter Gauge 4 Fr | Not stated | Available |
| H965460430 | Lumen/Inner Diameter 0.018 in; Length 10 cm; Outer Diameter 1.4 mm; Catheter Gauge 4 Fr | Not stated | Available |
FDA clearances
- 510(k) K151239 June 2016
- 510(k) K153228 December 2015
Procedures that use implanted ports
Frequently asked questions
What is BioFlo 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?
BioFlo is made by AngioDynamics, Inc.. It is listed under implanted ports (port-a-cath), picc lines and midline catheters in our device library.
What sizes does BioFlo come in?
Sizes listed for BioFlo: Outer Diameter: 2.1–2.6 mm; Length: 63 cm; Catheter Gauge: 6–8 Fr. Confirm availability with the manufacturer's instructions for use.
Is BioFlo MRI safe?
The FDA device database lists BioFlo as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is BioFlo FDA cleared?
BioFlo is covered by FDA submissions K153228, K151239.
How do I contact a AngioDynamics, Inc. sales representative?
AngioDynamics, Inc. has not listed representatives on LA Vascular yet. Visit the AngioDynamics, 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.