Search Results

The SmartValve is a single use, sterile, non-pyrogenic pressure activated check valve system intended for use as an accessory to Intravascular administration set. The SmartValve provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein or artery). The SmartValve also provides access for the withdrawal of fluids from administration set.

The SmartValve is a single use, sterile, non-pyrogenic pressure activated valve intended for use as an accessory to Intravascular administration set.

This 510(k) notification describes a medical device, the SmartValve, which is an accessory to an Intravascular administration set. The provided documents focus on the regulatory approval process and device description, and do not contain information about acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval, equivalence to predicate devices, and general device information like material biocompatibility, rather than performance studies with quantitative acceptance criteria.

Ask a specific question about this device