SelectSite C304-HIS Deflectable Catheter System

Catheter, Percutaneous

Medtronic Inc.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Selectsite C304-his Deflectable Catheter System.

Pre-market Notification Details

Device IDK183493
510k NumberK183493
Device Name:SelectSite C304-HIS Deflectable Catheter System
ClassificationCatheter, Percutaneous
Applicant Medtronic Inc. Parkmore Business Park West Galway,  IE
ContactSharon Fahy
CorrespondentLinda O'connor
Medtronic Inc. Parkmore Business Park West Galway,  IE
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-17
Decision Date2019-03-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000147006 K183493 000
00763000147013 K183493 000

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