Device Type: Cardiovascular - Therapeutic
FDA Description:
An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboembolism, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another. Regulation Number: 870.5150.
General Description:
An embolectomy catheter is a medical device designed to remove blood clots or emboli from blood vessels, restoring proper blood flow in critical care and emergency situations. It is widely used in procedures to treat acute arterial or venous occlusions, such as those caused by deep vein thrombosis (DVT) or pulmonary embolism.
The catheter is made from flexible, medical-grade materials, such as polyurethane or silicone, to navigate through the vascular system with minimal trauma to vessel walls. At its distal end, the catheter typically features an inflatable balloon or other specialized tip designed to capture and extract clots. The catheter is guided into the affected vessel using imaging techniques such as fluoroscopy for precise placement.
Embolectomy catheters are available in various sizes to accommodate different vessel diameters and clinical scenarios. Single-lumen and dual-lumen designs provide versatility for both aspiration and irrigation during the procedure. These devices undergo rigorous testing to meet biocompatibility, durability, and safety standards.
Embolectomy catheters are indispensable in vascular surgery, interventional radiology, and cardiology, enabling effective clot removal and reducing the risk of long-term complications such as tissue damage or organ failure.
The Code of Federal Regulations (CFR) classifies and organizes over 1,700 devices into 16 medical specialty “panels” (such as Anesthesiology Devices or General Hospital and Personal Use Devices). Within these broad categories are 7-digit regulation numbers and associated device descriptions, including intended use, classification, and information about marketing requirements.