FlexCath Select Steerable Sheath (10 French)

Introducer, Catheter

Medtronic CryoCath LP

The following data is part of a premarket notification filed by Medtronic Cryocath Lp with the FDA for Flexcath Select Steerable Sheath (10 French).

Pre-market Notification Details

Device IDK142684
510k NumberK142684
Device Name:FlexCath Select Steerable Sheath (10 French)
ClassificationIntroducer, Catheter
Applicant Medtronic CryoCath LP 8200 Coral Sea Street NE Mail Stop MVS46 Mounds View,  MN  55112
ContactVanessa Ware
CorrespondentVanessa Ware
Medtronic CryoCath LP 8200 Coral Sea Street NE Mail Stop MVS46 Mounds View,  MN  55112
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-19
Decision Date2014-11-06
Summary:summary

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