Microcatheters
Wedge
A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.
Wedge 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 |
|---|---|---|---|
| MCWED21160 | — | Not stated | Available |
| MCWED21160-088 | — | Not stated | Available |
| MCWED21160-US | — | Not stated | Available |
FDA clearances
- 510(k) K232542 May 2024
- 510(k) K172014 April 2018
Procedures that use microcatheters
Frequently asked questions
What is Wedge used for?
A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.
Who makes Wedge?
Wedge is made by Microvention, Inc.. It is listed under microcatheters in our device library.
What sizes does Wedge come in?
The FDA device database does not list sizes for Wedge. Check the instructions for use or ask a Microvention, Inc. representative.
Is Wedge MRI safe?
The FDA device database entry for Wedge does not state its MRI safety status. Check the labeling before MRI.
Is Wedge FDA cleared?
Wedge is covered by FDA submissions K172014, K232542.
How do I contact a Microvention, Inc. sales representative?
Microvention, Inc. has not listed representatives on LA Vascular yet. Visit the Microvention, 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.