SWAN-GANZ VIP-CATHETER

K820222 · American Edwards Laboratories · DYG · Feb 12, 1982 · Cardiovascular

Device Facts

Record IDK820222
Device NameSWAN-GANZ VIP-CATHETER
ApplicantAmerican Edwards Laboratories
Product CodeDYG · Cardiovascular
Decision DateFeb 12, 1982
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.1240
Device ClassClass 2

Regulatory Classification

Identification

A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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