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510(k) K201057

Device
Bio-Medicus Life Support Catheter And Introducer
Applicant
Medtronic Inc.
510(k) number
K201057
Product code
QHW  
Decision
Substantially Equivalent (SESE)
Decision date
2022-01-14
Date received
2020-04-21
Regulation
870.4100
Classification name
Single Lumen Ecmo Cannula
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Juli Rubin
Address
8200 Coral Sea St. N.E Mounds View MN US 55112 55112

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QHW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251831Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc.2026-01-15
K240534Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc.2024-04-19

Legacy Summary#

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FDA Review#

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