Atherectomy
Stealth
by Cardiovascular Systems, Inc.
A sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This device is not intended for use in the coronary, carotid, iliac or renal vasculature. This is a single-use device.
Stealth 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 |
|---|---|---|---|
| DBE-150 | — | Not stated | Available |
| DBE-150 | Length 145 cm | Not stated | Available |
| DBE-200 | — | Not stated | Available |
| DBE-200 | Length 145 cm | Not stated | Available |
| PRD-MAX-200 | — | Not stated | Available |
| PRD-SC30-125 | — | Not stated | Available |
| PRD-SC30-125 | Length 145 cm | Not stated | Available |
| PRD-SC30-125S | — | Not stated | Available |
| PRD-SC30-150 | Length 145 cm | Not stated | Available |
| PRD-SC30-150 | — | Not stated | Available |
| PRD-SC30-200 | — | Not stated | Available |
| PRD-SC30-200 | Length 145 cm | Not stated | Available |
| PRD-SC30-225 | — | Not stated | Available |
| PRD-SC30-MICRO | Length 145 cm | Not stated | Available |
| RAD-SC30-125 | Length 200 cm | Not stated | Available |
| RAD-SC30-125 | — | Not stated | Available |
| RAD-SC30-150 | — | Not stated | Available |
| RAD-SC30-150 | Length 200 cm | Not stated | Available |
| RAD-SC30-175 | Length 180 cm | Not stated | Available |
| RAD-SC30-175 | — | Not stated | Available |
Procedures that use atherectomy
Frequently asked questions
What is Stealth used for?
A sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This device is not intended for use in the coronary, carotid, iliac or renal vasculature. This is a single-use device.
Who makes Stealth?
Stealth is made by Cardiovascular Systems, Inc.. It is listed under atherectomy devices in our device library.
What sizes does Stealth come in?
Sizes listed for Stealth: Length: 145–200 cm. Confirm availability with the manufacturer's instructions for use.
Is Stealth MRI safe?
The FDA device database entry for Stealth does not state its MRI safety status. Check the labeling before MRI.
Is Stealth FDA cleared?
Stealth is registered in the FDA's Global Unique Device Identification Database (GUDID).
How do I contact a Cardiovascular Systems, Inc. sales representative?
Cardiovascular Systems, Inc. has not listed representatives on LA Vascular yet. Visit the Cardiovascular Systems, 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.