DESCENDING ARCH CANNULA

K880421 · Dlp, Inc. · DWF · Apr 28, 1988 · Cardiovascular

Device Facts

Record IDK880421
Device NameDESCENDING ARCH CANNULA
ApplicantDlp, Inc.
Product CodeDWF · Cardiovascular
Decision DateApr 28, 1988
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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