(82 days)
The Vein Entry Indicator Device (VEID) is used to indicate the location of a vein, including indication of vein entry, vein double puncture, vein re-entry and vein exit of an I.V. catheter system needle.
Not Found
This document is a 510(k) clearance letter from the FDA for the "Vein Entry Indicator Device (VEID)". It confirms the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, study details, or performance data.
Therefore, I cannot provide the requested information. The letter only approves the marketing of the device based on its substantial equivalence. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) summary that includes performance data.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).