ENPATH DEFLECTABLE CATHETER

Catheter, Percutaneous

ENPATH MEDICAL INCORPORATED

The following data is part of a premarket notification filed by Enpath Medical Incorporated with the FDA for Enpath Deflectable Catheter.

Pre-market Notification Details

Device IDK043489
510k NumberK043489
Device Name:ENPATH DEFLECTABLE CATHETER
ClassificationCatheter, Percutaneous
Applicant ENPATH MEDICAL INCORPORATED 15301 HWY. 55 WEST Minneapolis,  MN  55447
ContactKaryl D Haskell
CorrespondentKaryl D Haskell
ENPATH MEDICAL INCORPORATED 15301 HWY. 55 WEST Minneapolis,  MN  55447
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-17
Decision Date2005-05-19
Summary:summary

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