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FDA 510(k)

Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter

K-Number: K252405 · 2025-11-26

ApplicantSurgical Instrument Service and Savings, Inc.
Decision Date2025-11-26
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter is a medical device manufactured by Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2025-11-26 under approval number K252405. 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 Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter?

Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter is a medical device that received FDA 510(k) clearance on 2025-11-26. It is manufactured by Surgical Instrument Service and Savings, Inc.. The 510(k) number is K252405.

When was Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter approved by the FDA?

Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter received FDA 510(k) clearance on 2025-11-26, under approval number K252405.

What company makes Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter?

Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter is manufactured by Surgical Instrument Service and Savings, Inc..

What is the FDA product code for Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter?

The FDA product code for Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter is NLH.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT05501873 Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System ACTIVE_NOT_RECRUITING NCT07595666 Comparison of NeuroEXPLORER PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region. ENROLLING_BY_INVITATION NCT04674969 Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature RECRUITING NCT07471308 P-wave Duration and Local Potential as Predictors of AF Recurrence Following Pulmonary Vein Isolation ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40708647 Multistakeholder scientific advice for medicinal products used in combination with a medical device or a companion diagnostic in the EU-summary of a Focus group discussion. Frontiers in medicine (2025)

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Related Devices (Code: NLH)

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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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