STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE

K001961 · Stoeckert Instrumente · DWF · Jan 25, 2001 · Cardiovascular

Device Facts

Record IDK001961
Device NameSTOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE
ApplicantStoeckert Instrumente
Product CodeDWF · Cardiovascular
Decision DateJan 25, 2001
DecisionSESE
Submission TypeAbbreviated
Regulation21 CFR 870.4210
Device ClassClass 2

Regulatory Classification

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.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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