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The Cordis TempoTM 4 Angiography Catheter is designed to deliver radiopaque contrast medium to selected sites in the vascular system.

The Cordis Tempo™ 4 Angiography catheter is a single lumen catheter consisting of polyamide and polyurethane materials with a proximal strain relief and hub. The catheters are available in various lengths and tip configurations and accept guidewires with diameters of 0.035" or 0.038" depending on the configuration.

The provided documentation is a 510(k) premarket notification for the Cordis Tempo™ 4 Angiography Catheter. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device and does not typically include the detailed performance study information requested for AI/software-based devices.

Therefore, the information requested in points 1-9 cannot be extracted from this document.

The document states:

• The Cordis Tempo™ 4 Angiography Catheter is similar in design, construction, indication for use and performance characteristics to other commercially available angiography catheters. This is the basis for its substantial equivalence, rather than a detailed study proving performance against specific acceptance criteria.
• All appropriate Biocompatibility tests were successfully performed on the materials used for the Cordis Tempo™ 4 Angiography Catheters per ISO 10993-1. This is a general statement about biocompatibility, not a performance study for the device's primary function as an angiography catheter.
• Performance standards have not been established by the FDA under Section 514 of the Food, Drug, and Cosmetic Act. This means there are no pre-defined, FDA-mandated performance metrics the device had to meet.

In summary, this document is a regulatory submission for a traditional medical device, not a software-driven or AI-based device, and as such, it does not contain the type of AI/ML performance study details requested.

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