Fecha de decisión2025-05-15
Código de productoLDF
Comité asesorCV
DecisiónSubstantially Equivalent
Resumen del dispositivo
Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2025-05-15 under 510(k) number K251186. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Preguntas frecuentes
What is the Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)?
Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) is a medical device that received FDA 510(k) clearance on 2025-05-15. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K251186.
When did Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) receive FDA 510(k) clearance?
Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) received FDA 510(k) clearance on 2025-05-15, under 510(k) number K251186.
Who is the listed applicant for Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)?
The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)?
The FDA product code for Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) is LDF.
Ensayos clínicos relacionados
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Otros registros que enlistan a C.R. Bard, Inc. como solicitante
Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.
K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitK252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)K251864Rubber Utility CatheterK241334Semi-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,K230356Aspirex™ Thrombectomy System Ver todos los 67 dispositivos →
Dispositivos relacionados (Código: LDF)
Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.
K252042Sync AV II Temporary Pacing CatheterSwift Sync, Inc.K242863Bioptimal Bipolar Pacing CatheterBioptimal International Pte. , Ltd.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
Fuente oficial
Ver en la base de datos de la FDA →Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.