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The Medtronic Angiographic Guide Wires are indicated for percutaneous entry into vessel using the Seldinger technique.

The Medtronic Angiographic Guide Wires are stainless steel guide wires that are constructed of an inner core wire, a safety wire and an outer spring coil. They have a polytetrafluoroethlyene coating and are available in a variety of configurations of length, diameter and other features.

The provided text is a 510(k) summary for the Medtronic Angiographic Guide Wires. It states that the submission does not contain information about studies proving the device meets acceptance criteria.

Instead, the summary explicitly states:

"There are no changes to the technological characteristics of the Medtronic Angiographic Guide Wires with this submission; characteristics such as product performance, design and intended use have remained the same."

And, crucially:

"The proposed Medtronic Angiographic Guide Wires has successfully passed all applicable testing."

Therefore, the submission relies on the concept of "substantial equivalence" to a predicate device (Medtronic Angiographic Guide Wires, Pre-Amendment, K772021 and K780438), rather than presenting new clinical study data to establish performance against acceptance criteria.

Based on the provided text, I cannot complete the requested information regarding acceptance criteria and a study proving the device meets them because such details are not present. The submission indicates that all applicable testing has been passed, but it does not specify what those tests were, their acceptance criteria, or the results.

If this were a submission for a novel device or one with significant changes, this information would be expected. However, for a 510(k) relying on substantial equivalence for an unchanged device, the focus is on demonstrating that the new device is fundamentally the same as a previously cleared predicate device.

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