KONTRON LITWAK-KOFFSKY OBTURATED CANNU

K821316 · Kontron Instruments, Inc. · DWF · Aug 6, 1982 · Cardiovascular

Device Facts

Record IDK821316
Device NameKONTRON LITWAK-KOFFSKY OBTURATED CANNU
ApplicantKontron Instruments, Inc.
Product CodeDWF · Cardiovascular
Decision DateAug 6, 1982
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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