(219 days)
AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
AngioDynamics Angiographic Catheters are sterile, single use, disposable devices designed to deliver radiopaque contrast media to selected sites in the vascular system. AngioDynamics Soft-Vu and Mariner Catheters come in the following sizes/structures:
| Soft-Vu | Mariner | |
|---|---|---|
| French Size | 4F, 5F, 6F | 4F, 5F |
| Shaft | Braided and Non-Braided | Braided and Non-Braided |
| Tip | Non-Braided | Non-Braided |
| Coating | Non-Coated | Coated |
| Lengths | 25cm - 150cm | 25cm - 150cm |
The only change presented in this 510(k) submission is a change to the colorant and the addition of heat and light stabilizers to the braided catheter shaft.
The provided text is a 510(k) summary for AngioDynamics Angiographic Catheters. This document details the process for obtaining substantial equivalence for a medical device but does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of a diagnostic algorithm or AI/ML model.
The "performance data" mentioned in section I only refers to non-clinical performance and material testing for the catheter itself (e.g., static pressure, tensile strength, biocompatibility), not a study assessing the diagnostic performance of software or an algorithm.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document is about a physical medical device (catheter), not a diagnostic algorithm or AI/ML device.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).