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FDA 510(k)

Livewire Electrophysiology Catheter

K-Number: K151617 · 2016-01-22

ApplicantSurgical Instrument Service and Savings Inc.(Dba Medline Ren
Decision Date2016-01-22
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Livewire Electrophysiology Catheter is a medical device manufactured by Surgical Instrument Service and Savings Inc.(Dba Medline Ren. It received FDA 510(k) clearance on 2016-01-22 under approval number K151617. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Livewire Electrophysiology Catheter?

Livewire Electrophysiology Catheter is a medical device that received FDA 510(k) clearance on 2016-01-22. It is manufactured by Surgical Instrument Service and Savings Inc.(Dba Medline Ren. The 510(k) number is K151617.

When was Livewire Electrophysiology Catheter approved by the FDA?

Livewire Electrophysiology Catheter received FDA 510(k) clearance on 2016-01-22, under approval number K151617.

What company makes Livewire Electrophysiology Catheter?

Livewire Electrophysiology Catheter is manufactured by Surgical Instrument Service and Savings Inc.(Dba Medline Ren.

What is the FDA product code for Livewire Electrophysiology Catheter?

The FDA product code for Livewire Electrophysiology Catheter is NLH.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT05685134 Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome COMPLETED NCT07210151 Anatomical Navigation for Guided Electrophysiology in AFL and AFib RECRUITING

Other Devices by Surgical Instrument Service and Savings Inc.(Dba Medline Ren

K153745Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector K182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider K193563Medline ReNewal Reprocessed Harmonic ACE+7 Shears K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)

Related Devices (Code: NLH)

K162251Reprocessed Viking Diagnostic Electrophysiology CathetersInnovative Health, LLC K161827Reprocessed Response Diagnostic Electrophysiology CathetersInnovative Health, LLC K160421Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP CatheterInnovative Health, LLC K161393Reprocessed Orbiter ST Steerable Diagnostic EP CatheterInnovative Health, LLC K161464Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology CathetersInnovative Health, LLC K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterSterilmed, 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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