FDA 510(k)

Medtronic Temporary External Pacemaker 53401

K-Number: K162054 · 2016-10-18

Decision Date2016-10-18

Product CodeDTE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Medtronic Temporary External Pacemaker 53401 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K162054. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medtronic Temporary External Pacemaker 53401?

Medtronic Temporary External Pacemaker 53401 is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Medtronic, Inc.. The 510(k) number is K162054.

When did Medtronic Temporary External Pacemaker 53401 receive FDA 510(k) clearance?

Medtronic Temporary External Pacemaker 53401 received FDA 510(k) clearance on 2016-10-18, under 510(k) number K162054.

Who is the listed applicant for Medtronic Temporary External Pacemaker 53401?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medtronic Temporary External Pacemaker 53401?

The FDA product code for Medtronic Temporary External Pacemaker 53401 is DTE.

Related Clinical Trials

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Other records listing Medtronic, Inc. as applicant

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Related Devices (Code: DTE)

K241781Solo Pace ControlSolo Pace, Inc.K232721Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K201011Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K182839Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K181973Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.