CATHETER, UMBILICAR ARTERY

Catheter, Umbilical Artery

AXIOM MEDICAL, INC.

The following data is part of a premarket notification filed by Axiom Medical, Inc. with the FDA for Catheter, Umbilicar Artery.

Pre-market Notification Details

Device IDK771022
510k NumberK771022
Device Name:CATHETER, UMBILICAR ARTERY
ClassificationCatheter, Umbilical Artery
Applicant AXIOM MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFOS  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-06-06
Decision Date1977-11-29

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