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K Number
K001961
Device Name
STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE
Manufacturer
STOECKERT INSTRUMENTE
Date Cleared
2001-01-25

(212 days)

Product Code
DWF
Regulation Number
870.4210
Type
Abbreviated
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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).