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HSA · registration DE0509877

Medtronic FlexCath Contour™ Steerable Sheath

SingaporeCardiovascularClass DMedtronic, Inc
Verified
Official record identity
Registration number
DE0509877
Model name
FlexCath Contour™; FlexCath Contour™; FlexCath Contour™; FlexCath Contour™
Model identifier
10FCC13; 10FCC20; 12FCC13; 12FCC20
Registration date
October 04, 2024
Classification
Risk class
Class D
Official value: CLASS D
Published category
Cardiovascular
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Published parties
Product owner
Medtronic, Inc
Registrant / registration holder
MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)
Official description

The intended purpose of FlexCath Contour steerable sheath is to provide percutaneous introduction into the vasculature and chambers of the heart, and to facilitate positioning of compatible devices.

Additional source fields
Product owner address
710 Medtronic Parkway, Minneapolis, MN 55432, United States
Registrant address
50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.