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FDA 510(k)

Bioptimal Bipolar Pacing Catheter

K-Number: K242863 · 2025-06-15

ApplicantBioptimal International Pte. , Ltd.
Decision Date2025-06-15
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bioptimal Bipolar Pacing Catheter is a medical device manufactured by Bioptimal International Pte. , Ltd.. It received FDA 510(k) clearance on 2025-06-15 under approval number K242863. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bioptimal Bipolar Pacing Catheter?

Bioptimal Bipolar Pacing Catheter is a medical device that received FDA 510(k) clearance on 2025-06-15. It is manufactured by Bioptimal International Pte. , Ltd.. The 510(k) number is K242863.

When was Bioptimal Bipolar Pacing Catheter approved by the FDA?

Bioptimal Bipolar Pacing Catheter received FDA 510(k) clearance on 2025-06-15, under approval number K242863.

What company makes Bioptimal Bipolar Pacing Catheter?

Bioptimal Bipolar Pacing Catheter is manufactured by Bioptimal International Pte. , Ltd..

What is the FDA product code for Bioptimal Bipolar Pacing Catheter?

The FDA product code for Bioptimal Bipolar Pacing Catheter is LDF.

Related Clinical Trials

NCT06011252 Pacing Characteristics of a Conventional Bipolar ACTIVE_NOT_RECRUITING NCT06713668 Augmented Pacing for Shock in the Cardiac Intensive Care Unit ACTIVE_NOT_RECRUITING NCT07563257 Comparative Evaluation of Optrell and Octaray Mapping Catheters for Conduction Block Confirmation and Voltage Assessment During Atrial Ablation NOT_YET_RECRUITING NCT06606288 Characterizing Outcomes and Real-World Experience of Cardiac Physiologic Pacing (The CORE-CPP Study) ACTIVE_NOT_RECRUITING NCT07531368 BBAP With CS Mapping Guidance NOT_YET_RECRUITING NCT07505589 Pacing In Organ Donors (the POD Trial) COMPLETED

Related Devices (Code: LDF)

K161873Pacel Flow Directed Pacing CatheterSt Jude Medical K160260Tempo Temporary Pacing LeadBiotrace Medical, Inc. K161249Streamline 6495 Bipolar Temporary Myocardial Pacing LeadMedtronic K171253Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing LeadMedtronic K173923Temporary Cardiac Pacing WireETHICON, Inc. K190716Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing LeadMedtronic

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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