Guidewires
SET Aspirex S 8F 85cm
A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing acute vascular obstruction in native and stented blood vessels, or in native and synthetic bypass or haemodialysis access grafts, through a mechanical rotational action intended to erode and aspirate the obstruction for removal. It typically consists of a rotational catheter body/head powered by a magnetic power transmission provided by a connected control unit; ancillary device such as catheter guidewires, sterile cable covers, and collecting bags may be included. This is a single-use device.
SET Aspirex S 8F 85cm 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 |
|---|---|---|---|
| 80324 | Catheter Gauge 6 Fr; Catheter Working Length 110 cm | MR Unsafe | Available |
| 80325 | Catheter Gauge 6 Fr; Catheter Working Length 135 cm | MR Unsafe | Available |
| 80326 | Catheter Gauge 8 Fr; Catheter Working Length 85 cm | MR Unsafe | Available |
| 80327 | Catheter Gauge 8 Fr; Catheter Working Length 110 cm | MR Unsafe | Available |
| 80328 | Catheter Gauge 10 Fr; Catheter Working Length 110 cm | MR Unsafe | Available |
FDA clearances
- 510(k) K230356 March 2023
- 510(k) K220270 June 2022
Procedures that use guidewires
Frequently asked questions
What is SET Aspirex S 8F 85cm used for?
A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing acute vascular obstruction in native and stented blood vessels, or in native and synthetic bypass or haemodialysis access grafts, through a mechanical rotational action intended to erode and aspirate the obstruction for removal. It typically consists of a rotational catheter body/head powered by a magnetic power transmission provided by a connected control unit; ancillary device such as catheter guidewires, sterile cable covers, and collecting bags may be included. This is a single-use device.
Who makes SET Aspirex S 8F 85cm?
SET Aspirex S 8F 85cm is made by Straub Medical AG. It is listed under guidewires, mechanical thrombectomy devices in our device library.
What sizes does SET Aspirex S 8F 85cm come in?
Sizes listed for SET Aspirex S 8F 85cm: Catheter Gauge: 6–10 Fr; Catheter Working Length: 85–135 cm. Confirm availability with the manufacturer's instructions for use.
Is SET Aspirex S 8F 85cm MRI safe?
The FDA device database lists SET Aspirex S 8F 85cm as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is SET Aspirex S 8F 85cm FDA cleared?
SET Aspirex S 8F 85cm is covered by FDA submissions K220270, K230356.
How do I contact a Straub Medical AG sales representative?
Straub Medical AG has not listed representatives on LA Vascular yet. Visit the Straub Medical AG 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.