Vascular Solutions, LLC - FDA 510(k) Cleared Devices

Vascular Solutions, LLC is an interventional medical device company now part of Teleflex. The company specializes in cardiovascular devices for coronary and peripheral interventions, structural heart procedures, and mechanical circulatory support. Vascular Solutions operates with a manufacturing facility in Maple Grove, Minnesota.

The company has received 11 FDA 510(k) clearances from 11 total submissions since its first clearance in 2019. Cardiovascular devices represent 91% of its regulatory submissions. The latest clearance was in 2024, demonstrating continued product innovation and active market presence.

Vascular Solutions' cleared device portfolio includes guidewires, catheters, perfusion balloon systems, and vascular closure devices. Notable products span coronary interventions, peripheral vascular access, and temporary pacing applications. The company's product line reflects a focus on interventional tools designed to support complex procedural workflows.

Explore the complete list of device names, product codes, and clearance dates in the 510(k) database to review Vascular Solutions' full regulatory history.

3 devices have linked clinical trials registered on ClinicalTrials.gov.