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FDA 510(k)

Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter

K-Number: K221067 · 2023-05-31

ApplicantSurgical Instrument Service and Savings, Inc.
Decision Date2023-05-31
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter is a medical device manufactured by Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2023-05-31 under approval number K221067. 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 Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter?

Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter is a medical device that received FDA 510(k) clearance on 2023-05-31. It is manufactured by Surgical Instrument Service and Savings, Inc.. The 510(k) number is K221067.

When was Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter approved by the FDA?

Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter received FDA 510(k) clearance on 2023-05-31, under approval number K221067.

What company makes Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter?

Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter is manufactured by Surgical Instrument Service and Savings, Inc..

What is the FDA product code for Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter?

The FDA product code for Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable 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 NCT07612683 Pulmonary Artery Catheters in Cardiac Surgery NOT_YET_RECRUITING NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT07610681 Midline Catheter Study ACTIVE_NOT_RECRUITING NCT05685134 Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome COMPLETED

Related PubMed Literature

PMID: 40549731 Assessment of digital therapeutics in decentralized clinical trials: A scoping review. PLOS digital health (2025)

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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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