FlexCath Advance Steerable Sheath And Dilator

Catheter, Steerable

Medtronic CryoCath LP

The following data is part of a premarket notification filed by Medtronic Cryocath Lp with the FDA for Flexcath Advance Steerable Sheath And Dilator.

Pre-market Notification Details

Device IDK202620
510k NumberK202620
Device Name:FlexCath Advance Steerable Sheath And Dilator
ClassificationCatheter, Steerable
Applicant Medtronic CryoCath LP 8200 Coral Sea Street NE, MVS 46 Mounds View,  MN  55112
ContactMatthew Lobeck
CorrespondentMatthew Lobeck
Medtronic CryoCath LP 8200 Coral Sea Street NE, MVS 46 Mounds View,  MN  55112
Product CodeDRA  
CFR Regulation Number870.1280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-10
Decision Date2020-11-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000418052 K202620 000

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