FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211

• K Number: K960965
• Device Name: FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211
• Manufacturer: COEUR LABORATORIES, INC.
• Date Cleared: 1996-09-12 ( 185 days)
• Product Code: DXT
• Regulation Number: 870.1650
• Type: Traditional
• Panel: Cardiovascular
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: K030580 , K051799 , K070798 , K170431 , K983382

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.