Embolic protection
ProCatid System kit Finished Good
A steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. This is a single-use device.
Where to buy ProCatid System kit Finished Good
We do not have contact details for Gardia Medical Ltd yet. Send a request and we will route it to the right person for your country.
ProCatid System kit Finished Good 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 |
|---|---|---|---|
| P2-9-0705-S | — | Not stated | Available |
FDA clearances
- 510(k) K143570 June 2015
Procedures that use embolic protection
Frequently asked questions
What is ProCatid System kit Finished Good used for?
A steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. This is a single-use device.
Who makes ProCatid System kit Finished Good?
ProCatid System kit Finished Good is made by Gardia Medical Ltd. It is listed under embolic protection devices in our device library.
What sizes does ProCatid System kit Finished Good come in?
The FDA device database does not list sizes for ProCatid System kit Finished Good. Check the instructions for use or ask a Gardia Medical Ltd representative.
Is ProCatid System kit Finished Good MRI safe?
The FDA device database entry for ProCatid System kit Finished Good does not state its MRI safety status. Check the labeling before MRI.
Is ProCatid System kit Finished Good FDA cleared?
ProCatid System kit Finished Good is covered by FDA submission K143570.
How do I contact a Gardia Medical Ltd sales representative?
Gardia Medical Ltd has not listed representatives on LA Vascular yet. Visit the Gardia Medical Ltd 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.