(475 days)
The Balloon Angiographic catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be used to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart.
Harmac Balloon Angiographic Catheter
This document is a 510(k) clearance letter from the FDA for a medical device (Harmac Balloon Angiographic Catheter). It does not contain any information about acceptance criteria, device performance reporting, or a study that proves the device meets acceptance criteria.
The letter explicitly states that the FDA has reviewed the Section 510(k) notification of intent to market the device and determined it is "substantially equivalent" to devices marketed prior to May 28, 1976. This is a regulatory pathway for medical devices that are similar to existing legally marketed devices, and often does not require new clinical studies demonstrating safety and effectiveness compared to devices undergoing a Premarket Approval (PMA) pathway.
Therefore, I cannot extract the requested information from the provided text. The document is solely a regulatory clearance for market entry based on substantial equivalence, not a performance study report.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).