(173 days)
The Galtstick™ Introduce system is indicated for percutaneous introduction and place of catheters and guidewires.
The Galtstick™ device adds a stiffening cannula with an attached hub for ease of insertion into the body.
The provided text is related to a 510(k) premarket notification for a medical device called the "Galtstick™ Introducer System." This document is a letter from the FDA to Galt Medical Corporation, notifying them that their device has been found substantially equivalent to a legally marketed predicate device.
This document does not describe acceptance criteria for device performance or a study proving that the device meets such criteria.
The content relates to regulatory clearance based on substantial equivalence to a predicate device, rather than a performance study with defined acceptance criteria and results. The information provided is primarily administrative and regulatory. Therefore, I cannot extract the requested information about acceptance criteria and a study from this document.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).