Vantis Vascular Receives FDA Clearance for 6F CrossFAST Model

Vantis Vascular received U.S. Food and Drug Administration 510(k) clearance for a new 6 French model of its CrossFAST Integrated Microcatheter Advanced Delivery System, according to Yahoo News.

The announcement identifies Vantis Vascular as a medical technology company developing devices for vascular interventions. The FDA clearance applies to the new 6F CrossFAST model.

FDA clearance for the 6F CrossFAST model

Yahoo News reported that the regulatory milestone is FDA 510(k) clearance. The cleared device is a new 6 French, or 6F, model within Vantis Vascular’s CrossFAST product offering.

Vantis Vascular calls CrossFAST an Integrated Microcatheter Advanced Delivery System. The supplied report does not include further details about clinical use, performance, procedures, or product specifications beyond the device name and new 6F model.

Vascular intervention device portfolio update

The clearance is a product and regulatory update for professionals following vascular intervention technologies. Yahoo News’ report centers on the addition of the 6F CrossFAST model and Vantis Vascular’s FDA 510(k) clearance announcement.

For medical-device sales professionals, the news offers a confirmed reference point for conversations involving manufacturer product portfolios in vascular interventions. It also distinguishes the reported regulatory action from clinical or commercial details that were not included in the supplied summary.

What Yahoo News reported

• Vantis Vascular received FDA 510(k) clearance.
• The clearance covers a new 6F CrossFAST model.
• CrossFAST is described as an Integrated Microcatheter Advanced Delivery System.
• Vantis Vascular develops devices for vascular interventions.

Yahoo News did not provide additional information in the supplied report regarding the device’s performance, procedural application, clinical evidence, or availability. The confirmed event is the FDA 510(k) clearance for the new 6F CrossFAST model.