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FDA 510(k)

Medtronic Temporary External Pacemaker 53401

K-Number: K162054 · 2016-10-18

ApplicantMedtronic, Inc.
Decision Date2016-10-18
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Medtronic Temporary External Pacemaker 53401 is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2016-10-18 under approval 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. It is manufactured by Medtronic, Inc.. The 510(k) number is K162054.

When was Medtronic Temporary External Pacemaker 53401 approved by the FDA?

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

What company makes Medtronic Temporary External Pacemaker 53401?

Medtronic Temporary External Pacemaker 53401 is manufactured by Medtronic, Inc..

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 Devices by Medtronic, Inc.

K162896Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface K162892Achieve Advance Mapping Catheter K162550Medtronic Model 5392 External Pulse Generator (EPG) K162016Affinity NT Oxygenator with Cortiva BioActive Surface K160983Kyphon HV-R Bone Cement K160809Reveal LINQ

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Related Devices (Code: DTE)

K162550Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. K181973Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. K180873Medtronic Model 53401 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. K201011Medtronic 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.

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