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With drawal cannula for single use sterile transfer of liquid from a syrings vial and vice versa. Air enters and exits the through a hydrophobic membrane which avoide extraneous contamination of the vist and syringe contents and prevents liquid aerosols from escaping into the environment. The integrated fluid filter provides for reliable filtration o particles and ensures a high degree of safety patient.

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This document is a 510(k) clearance letter from the FDA for a device called "Taky-Spike Plus". It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it predates the widespread use of such detailed AI/ML study reporting in regulatory submissions.

Therefore, I cannot extract the requested information from the provided text. The document is primarily focused on confirming the device's substantial equivalence to a legally marketed predicate device and outlining general regulatory obligations.

The device itself, "Taky-Spike Plus," is described as a "withdrawal cannula for single use sterile transfer of liquid from a syringe to a vial and vice versa." It features a hydrophobic membrane for air exchange and an integrated fluid filter. This description clearly indicates it is a physical medical device, not an AI/ML-driven software or diagnostic tool that would typically have the kind of performance metrics and study details you're asking for.

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