VascuTech Medical, LLC - FDA 510(k) Cleared Devices

VascuTech Medical, LLC is a medical device manufacturer specializing in vascular access devices. The company develops and manufactures catheters, dilators, introducers, trocars, tunnelers, and needles for interventional radiology, interventional cardiology, pain management, and urology. VascuTech operates a vertically integrated manufacturing facility in Oaks, Pennsylvania.

The company has received 1 FDA 510(k) clearance from 1 total submission. VascuTech's regulatory focus is Cardiovascular devices, with its most recent clearance in 2026. The company maintains active FDA and ISO 13485 registration.

VascuTech manufactures Class I, Class II, and Class III devices. The company offers contract manufacturing services ranging from process development and rapid prototyping to full-scale production. Its product portfolio includes dialysis catheters, balloon angiography catheters, drug delivery catheters, hemostasis valves, and biopsy needles.

Explore the company's cleared device names, product codes, and clearance dates in the database.