Guidewires
OptoWire
by Opsens Inc
A device intended to be incorporated into the distal end of a catheter (not included) to measure pressure. It typically consists of a pressure sensor (e.g., a flexible membrane or diaphragm) and a means to convert the detected pressure into electronic signals or possibly ultrasonic signals which are transmitted via a cable or wireless to an external parent device (e.g., a manometer) that processes the signals and displays the results. It is used for invasive measurement of pressure in places such as the central and/or peripheral vasculature, cranium, uterus (typically during labour), pleura, and also in the urinary bladder/urethra (e.g., during urodynamic tests). This is a single-use device.
OptoWire 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 |
|---|---|---|---|
| Deux | Length 175 cm | Not stated | Available |
| III | Length 180 cm | MR Unsafe | Available |
FDA clearances
- 510(k) K191907 January 2020
- 510(k) K152991 February 2016
Procedures that use guidewires
Frequently asked questions
What is OptoWire used for?
A device intended to be incorporated into the distal end of a catheter (not included) to measure pressure. It typically consists of a pressure sensor (e.g., a flexible membrane or diaphragm) and a means to convert the detected pressure into electronic signals or possibly ultrasonic signals which are transmitted via a cable or wireless to an external parent device (e.g., a manometer) that processes the signals and displays the results. It is used for invasive measurement of pressure in places such as the central and/or peripheral vasculature, cranium, uterus (typically during labour), pleura, and also in the urinary bladder/urethra (e.g., during urodynamic tests). This is a single-use device.
Who makes OptoWire?
OptoWire is made by Opsens Inc. It is listed under guidewires in our device library.
What sizes does OptoWire come in?
Sizes listed for OptoWire: Length: 175–180 cm. Confirm availability with the manufacturer's instructions for use.
Is OptoWire MRI safe?
The FDA device database lists OptoWire as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is OptoWire FDA cleared?
OptoWire is covered by FDA submissions K191907, K152991.
How do I contact a Opsens Inc sales representative?
Opsens Inc has not listed representatives on LA Vascular yet. Visit the Opsens 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.