Atherectomy
RotarexS 8 F x 85 cm
A sterile catheter with attached handpiece, with a power-driven cutting or abrasive head intended to mechanically disrupt/remove atheroma plaque from the walls of both coronary and peripheral arteries. The operator regulates the energy via a remote control or foot-switch attached to the generator. The handpiece may also serve as a conduit for irrigation, aspiration and placement of a guidewire during surgery. This is a single-use device.
RotarexS 8 F x 85 cm 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 |
|---|---|---|---|
| 80332 | Catheter Gauge 6 Fr; Catheter Working Length 110 cm | MR Unsafe | Available |
| 80333 | Catheter Gauge 6 Fr; Catheter Working Length 135 cm | MR Unsafe | Available |
| 80334 | Catheter Gauge 8 Fr; Catheter Working Length 85 cm | MR Unsafe | Available |
| 80335 | Catheter Gauge 8 Fr; Catheter Working Length 110 cm | MR Unsafe | Available |
FDA clearances
- 510(k) K172315 April 2018
Procedures that use atherectomy
Frequently asked questions
What is RotarexS 8 F x 85 cm used for?
A sterile catheter with attached handpiece, with a power-driven cutting or abrasive head intended to mechanically disrupt/remove atheroma plaque from the walls of both coronary and peripheral arteries. The operator regulates the energy via a remote control or foot-switch attached to the generator. The handpiece may also serve as a conduit for irrigation, aspiration and placement of a guidewire during surgery. This is a single-use device.
Who makes RotarexS 8 F x 85 cm?
RotarexS 8 F x 85 cm is made by Straub Medical AG. It is listed under atherectomy devices in our device library.
What sizes does RotarexS 8 F x 85 cm come in?
Sizes listed for RotarexS 8 F x 85 cm: Catheter Gauge: 6–8 Fr; Catheter Working Length: 85–135 cm. Confirm availability with the manufacturer's instructions for use.
Is RotarexS 8 F x 85 cm MRI safe?
The FDA device database lists RotarexS 8 F x 85 cm as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is RotarexS 8 F x 85 cm FDA cleared?
RotarexS 8 F x 85 cm is covered by FDA submission K172315.
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.