INTRACARDIA SUCKERS

K831759 · Research Industries Corp. · DWF · Aug 12, 1983 · Cardiovascular

Device Facts

Record IDK831759
Device NameINTRACARDIA SUCKERS
ApplicantResearch Industries Corp.
Product CodeDWF · Cardiovascular
Decision DateAug 12, 1983
DecisionSESE
Submission TypeTraditional
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
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