NRG TRANSSEPTAL NEEDLE

Catheter, Septostomy

BAYLIS MEDICAL CO., INC.

The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Nrg Transseptal Needle.

Pre-market Notification Details

Device IDK073326
510k NumberK073326
Device Name:NRG TRANSSEPTAL NEEDLE
ClassificationCatheter, Septostomy
Applicant BAYLIS MEDICAL CO., INC. 2645 MATHESON BLVD. E Mississauga, Ontario,  CA L4w 5s4
ContactMeghal Khakhar
CorrespondentMeghal Khakhar
BAYLIS MEDICAL CO., INC. 2645 MATHESON BLVD. E Mississauga, Ontario,  CA L4w 5s4
Product CodeDXF  
CFR Regulation Number870.5175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-27
Decision Date2008-05-28
Summary:summary

NIH GUDID Devices

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