BAXTER HEMOSTASIS VALVE INTRODUCERS

Introducer, Catheter

BAXTER EDWARDS

The following data is part of a premarket notification filed by Baxter Edwards with the FDA for Baxter Hemostasis Valve Introducers.

Pre-market Notification Details

Device IDK981909
510k NumberK981909
Device Name:BAXTER HEMOSTASIS VALVE INTRODUCERS
ClassificationIntroducer, Catheter
Applicant BAXTER EDWARDS 17221 RED HILL AVE. Irvine,  CA  92614 -5627
ContactScott Beggins
CorrespondentScott Beggins
BAXTER EDWARDS 17221 RED HILL AVE. Irvine,  CA  92614 -5627
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-06-01
Decision Date1998-11-24
Summary:summary

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