SARNS MEDIASTINAL AND PERICARDIAL TUBE

K792070 · 3M Health Care, Sarns · DWF · Nov 21, 1979 · Cardiovascular

Device Facts

Record IDK792070
Device NameSARNS MEDIASTINAL AND PERICARDIAL TUBE
Applicant3M Health Care, Sarns
Product CodeDWF · Cardiovascular
Decision DateNov 21, 1979
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
Classification Order
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