(73 days)
The Medcomp H-Cath Central Venous Access Catheter is designed for long-term central venous access. It can be used for total parenteral nutrition (TPN), infusion of I.V. liquids, blood, blood products and drugs. It can also be used for repeated withdrawal of blood samples.
Medcomp H-Cath Triple Lumen Central Venous Access Catheter
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment. This document is a 510(k) clearance letter from the FDA for a medical device (Medcomp H-Cath Triple Lumen Central Venous Access Catheter), confirming its substantial equivalence to a predicate device. It does not include the results of any performance studies or details about their methodology.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”