STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB

• K Number: K001565
• Device Name: STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB
• Manufacturer: EDWARDS LIFESCIENCES, LLC.
• Date Cleared: 2000-08-10 ( 83 days)
• Product Code: DWF
• Regulation Number: 870.4210
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: N/A
• Predicate For: K090869 , K123187

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

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).