(175 days)
The LeMaitre Balloon Catheter with Irrigation is indicated for the extraction of emboli and thrombi from the peripheral arterial system and also may be used for infusion of fluids.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA to a medical device manufacturer for a LeMaitre Balloon Catheter with Irrigation, stating that the device is substantially equivalent to legally marketed predicate devices. It outlines the indications for use but does not present any performance study data, acceptance criteria, sample sizes, expert qualifications, or other details typically found in a clinical or performance study report.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).