(85 days)
The Cordis CINCH® OR Steerable Guidewire Extension is designed to extend Cordis Steerable Guidewires so that a catheter can be exchanged for another catheter
The CINCH® QR Steerable Guidewire Extension is a flexible stainless steel wire coated with DURAGLIDETM . The extension is 145 cm long and has a shaft diameter of 0.014 inches.
This document is a 510(k) premarket notification for a medical device (Cordis CINCH® QR Steerable Guidewire Extension). It is not a study report demonstrating the device meets acceptance criteria, nor does it contain information about clinical performance or AI algorithm validation.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory submission details like device description, intended use, and equivalence to predicate devices, and explicitly states that "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act." and "Biocompatibility testing was not repeated".
To answer your questions, I would need a different type of document, such as a clinical study report or a validation study for an AI-powered device.
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NOV - 7 1996
Image /page/0/Picture/1 description: The image shows a series of numbers and a letter, all in a bold, black font. The characters are 'K963171'. The numbers are unevenly spaced and appear to be handwritten or stamped. The background is white.
PREMARKET NOTIFICATION 510(k) Cordis Corporation Cinch® QR Steerable Guidewire Extension
SUMMARY OF SAFETY AND EFFECTIVENESS
I. General Provisions
Common or Usual Name: Catheter Guide Wire (Accessory) Proprietary Name: Cordis CINCH® QR Steerable Guidewire Extension
II. Name of Predicate Devices
CINCH® 3 Steerable Guidewire Extension
III. Classification
Catheter Guide Wire Accessory, Class II - 21 CFR 870.1330
IV. Performance Standards
Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
V. Intended Use and Device Description
The Cordis CINCH® OR Steerable Guidewire Extension is designed to extend Cordis Steerable Guidewires so that a catheter can be exchanged for another catheter
The CINCH® QR Steerable Guidewire Extension is a flexible stainless steel wire coated with DURAGLIDETM . The extension is 145 cm long and has a shaft diameter of 0.014 inches.
VI. Biocompatibility
Biocompatibility testing was not repeated since the CINCH® QR and the currently marketed CINCH® 3 (K914863) Steerable Guidewire Extensions are made of the same materials. The DURAGLIDE™ coating and method of application have also been cleared for use with the WIZDOM™ Steerable Guidewire (K953760).
§ 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.