FlexCath Select Steerable Shealth And Dilator

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 Shealth And Dilator.

Pre-market Notification Details

Device IDK163268
510k NumberK163268
Device Name:FlexCath Select Steerable Shealth And Dilator
ClassificationIntroducer, Catheter
Applicant Medtronic CryoCath LP 8200 Coral Sea Street NE, Mail Stop MVS46 Mail Stop MVS46 Mounds View,  MN  55112
ContactNatalie Sadeghi
CorrespondentNatalie Sadeghi
Medtronic CryoCath LP 8200 Coral Sea Street NE, Mail Stop MVS46 Mail Stop MVS46 Mounds View,  MN  55112
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-21
Decision Date2017-02-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169688858 K163268 000
00763000279905 K163268 000

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