Vascular Solutions, Inc. - FDA 510(k) Cleared Devices

Vascular Solutions, Inc. specialized in cardiovascular interventional devices with a manufacturing facility in Minneapolis, US. The company developed a broad portfolio of catheters, guidewires, and vascular access systems for interventional cardiology and radiology procedures.

The company received 102 FDA 510(k) clearances from 103 total submissions between 2002 and 2018. All submissions in the regulatory record were cleared. Cardiovascular devices dominated the company's portfolio, including mechanical thrombectomy systems, aspiration systems, guidewires, and vascular closure technologies. The company is now inactive, with no clearances recorded in more than five years.

Notable cleared devices include the Octane Mechanical Thrombectomy System, Bandit and Raider guidewires, TrapLiner catheter, and Gel-Bead embolic microspheres. The company's product range spanned coronary interventions, peripheral vascular access, and hemostasis solutions.

Explore the complete regulatory history, device names, product codes, and clearance dates in the 510(k) database.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.