SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER

K924661 · Baxter Healthcare Corp · KRA · Apr 8, 1993 · Cardiovascular

Device Facts

Record IDK924661
Device NameSWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER
ApplicantBaxter Healthcare Corp
Product CodeKRA · Cardiovascular
Decision DateApr 8, 1993
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.1210
Device ClassClass 2

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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