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510(k) K240534

Device
Bio-Medicus Life Support Catheter and Introducer
Applicant
Medtronic, Inc.
510(k) number
K240534
Product code
QHW
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-19
Date received
2024-02-26
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
Anna Wetherille
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
K201057Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc.2022-01-14