Microcatheters
CrossFAST(TM)
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.
CrossFAST(TM) 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 |
|---|---|---|---|
| CFM55 | — | Not stated | Available |
FDA clearances
- 510(k) K242276 September 2024
Procedures that use microcatheters
Frequently asked questions
What is CrossFAST(TM) 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 CrossFAST(TM)?
CrossFAST(TM) is made by Vantis Vascular, Inc.. It is listed under microcatheters in our device library.
What sizes does CrossFAST(TM) come in?
The FDA device database does not list sizes for CrossFAST(TM). Check the instructions for use or ask a Vantis Vascular, Inc. representative.
Is CrossFAST(TM) MRI safe?
The FDA device database entry for CrossFAST(TM) does not state its MRI safety status. Check the labeling before MRI.
Is CrossFAST(TM) FDA cleared?
CrossFAST(TM) is covered by FDA submission K242276.
How do I contact a Vantis Vascular, Inc. sales representative?
Vantis Vascular, Inc. has not listed representatives on LA Vascular yet. Visit the Vantis Vascular, 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.