FDA 510(k)

Bioptimal Bipolar Pacing Catheter

Numéro K : K242863 · 2025-06-15

DemandeurBioptimal International Pte. , Ltd.

Date de décision2025-06-15

Code produitLDF

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Bioptimal International Pte. , Ltd.. The 510(k) number is K242863.

When did Bioptimal Bipolar Pacing Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Bioptimal Bipolar Pacing Catheter?

The FDA 510(k) record lists Bioptimal International Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Essais cliniques associés

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Autres dossiers indiquant Bioptimal International Pte. , Ltd. en tant que demandeur

K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N

Dispositifs connexes (Code : LDF)

K252042Sync AV II Temporary Pacing CatheterSwift Sync, Inc.K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)C.R. Bard, Inc.K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,C.R. Bard, Inc.K241199Rotatable Connector (5944RL)Shenzhen Launch Electrical Co., Ltd.K242705Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)Medtronic, Inc.K232261TME Temporary Myocardial ElectrodeOsypka AG

Source officielle

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