(98 days)
The Occlusion Perfusion Catheter™ is indicated for localized infusion of various diagnostic and therapeutic agents into the peripheral vasculature. It is not indicated for use in the neurovasculature.
Not Found
I apologize, but the provided text from the FDA 510(k) clearance letter for the "Occlusion Perfusion Catheter™" does not contain the detailed information necessary to answer your request regarding acceptance criteria and the study that proves the device meets those criteria.
The document primarily focuses on the FDA's determination of substantial equivalence to a predicate device, the regulatory class, product code, and general regulatory requirements. It includes the device name and its Indications for Use.
It does not include:
- A table of acceptance criteria and reported device performance.
- Details about specific studies, sample sizes, data provenance, ground truth establishment, or expert qualifications.
- Information about MRMC studies or standalone algorithm performance.
To find this type of information, you would typically need to review the original 510(k) submission itself, which includes the detailed testing and performance data submitted by the manufacturer to the FDA. The letter provided is merely the FDA's official response to that submission.
§ 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).