(89 days)
The Cordis ST Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
The Cordis ST Steerable Guidewire incorporates a stainless steel corewire and radiopaque coil. The shaft is coated with PTFE.
This document describes a premarket notification for a medical device (Cordis ST Steerable Guidewire). It does not contain information about software or AI, nor does it detail a study involving acceptance criteria for device performance. Instead, it focuses on general device description, classification, and biocompatibility.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. These details are typically found in documents related to performance testing, often for software-based medical devices or devices undergoing specific clinical trials.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.