Coils
Orbit Galaxy Xtrasoft
A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.
Orbit Galaxy Xtrasoft 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 |
|---|---|---|---|
| 640CX0201 | Length 175 cm; Length 1.5 cm | MR Conditional | Available |
| 640CX0202 | Length 175 cm; Length 2 cm | MR Conditional | Available |
| 640CX0303 | Length 175 cm; Length 3 cm | MR Conditional | Available |
| 640CX0304 | Length 175 cm; Length 4 cm | MR Conditional | Available |
| 640CX0306 | Length 175 cm; Length 6 cm | MR Conditional | Available |
| 640CX0308 | Length 175 cm; Length 8 cm | MR Conditional | Available |
| 640CX0404 | Length 175 cm; Length 4 cm | MR Conditional | Available |
| 640CX0406 | Length 175 cm; Length 6 cm | MR Conditional | Available |
| 640CX0408 | Length 175 cm; Length 8 cm | MR Conditional | Available |
| 640CX0410 | Length 175 cm; Length 10 cm | MR Conditional | Available |
| 640CX2505 | Length 175 cm; Length 5 cm | MR Conditional | Available |
| 640CX2525 | Length 175 cm; Length 2.5 cm | MR Conditional | Available |
| 640CX2535 | Length 175 cm; Length 3.5 cm | MR Conditional | Available |
| 640CX3505 | Length 175 cm; Length 5 cm | MR Conditional | Available |
| 640CX3509 | Length 175 cm; Length 9 cm | MR Conditional | Available |
| 640CX3575 | Length 175 cm; Length 7.5 cm | MR Conditional | Available |
| 640HX0204 | Length 175 cm; Length 4 cm | MR Conditional | Available |
| 640HX0206 | Length 175 cm; Length 6 cm | MR Conditional | Available |
| 640HX0208 | Length 175 cm; Length 8 cm | MR Conditional | Available |
FDA clearances
- 510(k) K093973 May 2010
Procedures that use coils
Frequently asked questions
What is Orbit Galaxy Xtrasoft used for?
A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.
Who makes Orbit Galaxy Xtrasoft?
Orbit Galaxy Xtrasoft is made by Medos International Sàrl. It is listed under embolization coils in our device library.
What sizes does Orbit Galaxy Xtrasoft come in?
Sizes listed for Orbit Galaxy Xtrasoft: Length: 1.5–175 cm. Confirm availability with the manufacturer's instructions for use.
Is Orbit Galaxy Xtrasoft MRI safe?
The FDA device database lists Orbit Galaxy Xtrasoft as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Orbit Galaxy Xtrasoft FDA cleared?
Orbit Galaxy Xtrasoft is covered by FDA submission K093973.
How do I contact a Medos International Sàrl sales representative?
Medos International Sàrl has not listed representatives on LA Vascular yet. Visit the Medos International Sàrl 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.