VALVED PEELABLE INTRODUCER

Introducer, Catheter

MEDAMICUS, INC.

The following data is part of a premarket notification filed by Medamicus, Inc. with the FDA for Valved Peelable Introducer.

Pre-market Notification Details

Device IDK021004
510k NumberK021004
Device Name:VALVED PEELABLE INTRODUCER
ClassificationIntroducer, Catheter
Applicant MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis,  MN  55447
ContactKaryl Haskell
CorrespondentKaryl Haskell
MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis,  MN  55447
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-28
Decision Date2002-06-06
Summary:summary

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