Confida Adaptive Sheath

Introducer, Catheter

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Confida Adaptive Sheath.

Pre-market Notification Details

Device IDK152054
510k NumberK152054
Device Name:Confida Adaptive Sheath
ClassificationIntroducer, Catheter
Applicant Medtronic, Inc. 710 Medtronic Parkway Minneapolis,  MN  55432
ContactMatthew Lobeck
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2015-07-23
Decision Date2015-08-07
Summary:summary

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