(275 days)
To temporarily occlude an artery or vein with correct tension to produce minimal trauma to vessels. The different sizes and models are designed according to the type and size of the blood vessels, anatomical sites, and surgical techniques. Bulldog clamps are self-closing and are used for small vessels. The closing pressure of the GLOVER clamps can be adjusted using a nut and spring.
Applying forceps are used to apply bulldog clamps in deep surgical wounds.
To secure vascular occlusion of small vessels during surgery and to secure vascular occlusion during pediatric surgery.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer for "Vascular Clamps." This type of document is an approval based on substantial equivalence to a legally marketed predicate device, rather than a clinical study evaluating the performance of the device against specific acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, and multi-reader comparative effectiveness studies is not present in this document.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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...".
Therefore, I cannot provide the requested information based on the provided text.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).