(28 days)
THE JOMED GUIDING CATHETER IS INTENDED FOR USE FOR INTRAVASCULAR INTRODUCTION OF INTERVENTION AL/ DEAGNOSTIC DEVICES INTO THE CORONARY OR PERIPHERAL VASCULAR SYSTEMS.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the JOGUIDE Cardiovascular Guiding Catheter. This type of document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies as typically found in a clinical study report or a detailed pre-market submission.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This means the device was cleared based on its substantial equivalence to a predicate device, not necessarily on a novel clinical trial demonstrating specific performance metrics. Therefore, I cannot provide the requested information from this document.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).