MEDAMICUS PERCUTANEOUS INTRODUCER

Introducer, Catheter

MEDAMICUS, INC.

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

Pre-market Notification Details

Device IDK951313
510k NumberK951313
Device Name:MEDAMICUS PERCUTANEOUS INTRODUCER
ClassificationIntroducer, Catheter
Applicant MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis,  MN  55447
ContactDavid A Liebl
CorrespondentDavid A Liebl
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 Received1995-03-23
Decision Date1995-06-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20643169646333 K951313 000
00643169646162 K951313 000
00643169646179 K951313 000
00643169646186 K951313 000
00643169646193 K951313 000
00643169646216 K951313 000
20643169646272 K951313 000
20643169646289 K951313 000
20643169646296 K951313 000
20643169646302 K951313 000
20643169646319 K951313 000
00643169646155 K951313 000

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