STIFFER COAXIAL MICRO-INTRODUCER KIT

Introducer, Catheter

ENPATH MEDICAL, INC.

The following data is part of a premarket notification filed by Enpath Medical, Inc. with the FDA for Stiffer Coaxial Micro-introducer Kit.

Pre-market Notification Details

Device IDK071574
510k NumberK071574
Device Name:STIFFER COAXIAL MICRO-INTRODUCER KIT
ClassificationIntroducer, Catheter
Applicant ENPATH MEDICAL, INC. 2300 BERKSHIRE LANE NORTH Minneapolis,  MN  55441
ContactPatrice Stromberg
CorrespondentPatrice Stromberg
ENPATH MEDICAL, INC. 2300 BERKSHIRE LANE NORTH Minneapolis,  MN  55441
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-06-08
Decision Date2007-07-05
Summary:summary

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